Chronic bronchitis protocol
A MULTICENTRIC OPEN CLINICAL TRIAL
TO EVOLVE A GROUP OF EFFICACIOUS HOMOEOPATHIC MEDICINES IN
‘SIMPLE AND MUCOPURULENT CHRONIC BRONCHITIS’
WITH REGARD TO IMPROVEMENT IN THE SYMPTOM COMPLEX OF
‘SIMPLE AND MUCOPURULENT CHRONIC BRONCHITIS’
PROTOCOL TEAM
COORDINATORS including programme officers & investigators
I. CHIEF CO-ORDINATOR: PROF C. NAYAK , DIRECTOR, CCRH, New Delhi.
II.CO-CHIEF CO-ORDINATORS:
1. Dr. Vikram Singh, Assistant Director, CCRH, New Delhi.
2. Dr. Hari Singh, Research Officer, CCRH, New Delhi.
III. CO-ORDINATOR: Dr. (Mrs.) Jaya Gupta, Research Officer, CCRH, New Delhi.
IV. PROGRAMME OFFICERS/ INVESTIGATORS
City
Site
Centre
Programme
code
Officer
a Guwahati
RI
Regional
Dr S. K.
05
Research
Sharma
Institute
b Puri
RI
Regional
Dr. B. K.
04
Research
Mondal
Institute
c Kottayam
CI
Central
Dr. T.N.S.
01
Research
Kurup
Institute
d Chennai
CU
Clinical
Dr. K.S.V.
01
Research Unit
Bharathalaxmi
e
Bhopal
CE
01
f
Pondicherr
y
g
Tirupati
Investigator(s)
consultant
Dr S. K.
Sharma
medicine
Dr. B. K.
Mondal
medicine
Dr.S.
Gopinathan
medicine
Dr. K. Raju
medicine
Dr. D.D Arya
Dr. P.S.
Chakravorty
medicine
CU
15
Clinical
Research cum
Epidemic Cell
Clinical
Research Unit
Dr. S.
Bhuvneshwari
Dr. Prakash
Rao
medicine
CU
04
Clinical
Research Unit
Dr. G.Ravi
Chandra Reddy
Dr. R.V. R.
Prasad
medicine
BUDGET: Expenditure will be met by CCRH, New Delhi.
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Chronic bronchitis protocol
1.
INTRODUCTION
1.1
Literature review
Chronic bronchitis is a condition associated with excessive tracheobronchial
mucus production sufficient to cause cough with expectoration for at least 3
months of the year for more than 2 consecutive years. Simple Chronic bronchitis
describes a condition characterized by mucoid sputum production. Chronic
mucopurulent bronchitis is characterized by persistent or recurrent purulence of
sputum in the absence of localized suppurative diseases such as
bronchiectasis. Since there may or may not be obstruction as assessed by the
use of the forced expiratory vital capacity maneuver, chronic bronchitis with
obstruction deserves a separate classification. Cigarette smoking, air pollution,
occupations with exposure to inorganic organic gases, infections and familial
and genetic factors contribute to the pathogenesis of chronic bronchitis. The
difference between chronic bronchitis with obstruction and asthma is based
mainly on the history of the clinical illness. The patient with chronic bronchitis
with obstruction has a long history of cough and sputum production with a later
onset of wheezing, whereas the asthma patient with chronic obstruction gives a
long history of wheezing with later onset of chronic productive cough1
The clinical presentation varies in severity from simple chronic bronchitis without
disability to the severely disabled state with chronic respiratory failure. Despite
well-planned management, the patient with predominant bronchitis may
experience many episodes of respiratory failure from which recovery is frequent
with proper therapy 1
CCRH has conducted the study to see the effect of homoeopathic medicine on
Bronchitis. The cases which were registered were of Chronic Bronchitis and it is
found that homoeopathic medicines have helped in alleviating sign and
symptoms of Chronic Bronchitis2
It is apparent that so far no significant work has been done to elicit the efficacy
of homoeopathic medicines in chronic bronchitis and that there is no authentic
record of homoeopathic medicine(s) for the treatment of the disease, ‘Chronic
bronchitis’, in the homoeopathic repertories. As such, there is a need to explore
the efficacy of homoeopathic medicines otherwise indicated for the various
diagnostic symptoms of chronic bronchitis in the Homoeopathic literature.
1.2.
Classification:
Chronic bronchitis has been classified in the ICD-10, under item J41, as given
below 3 :
J41 Simple and mucopurulent chronic bronchitis
Excludes : Chronic bronchitis:

NOS (J42)

Obstructive (J44.-)
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Chronic bronchitis protocol
J41.0
Simple chronic bronchitis
J41.1
Mucopurulent chronic bronchitis
J41.8
Mixed simple and mucopurulent chronic
bronchitis
It is also clear from the classification of Chronic lower respiratory diseases (J4047) given in the ICD-10 that the following conditions will be excluded from the
purview of the current study:
1.3.

Cystic fibrosis (E84.-)

Bronchitis, not specified as acute or chronic (J40)

Unspecified chronic bronchitis (J42)

Emphysema (J42)

Other chronic obstructive pulmonary diseases (J44)

Asthma (J45)

Status asthmaticus (J46)
Usefulness:
The present study plans to evolve a group of efficacious homoeopathic
medicines in chronic bronchitis. It will define the indications of medicines found
effective in chronic bronchitis. This will be a valuable data for indexing in the
repertory and the same will immensely benefit the profession and the patients,
at large. The results of the study will also help in the verification of various
clinical/additional symptoms of the medicines. These medicines will provide a
gentle, safe and cost effective treatment of the disease.
2.
Study Objectives:
2.1
Hypothesis
For the open clinical trial, the primary hypothesis is that the use of medicines
selected on the basis of repertorisation of the diagnostic signs and symptoms of
chronic bronchitis and its characteristic symptoms, in single dose, in a specific
potency, would be effective in curing the patient suffering from chronic
bronchitis.
2.2. Primary Objective
2.3.
To carry out a multicentric open clinical trial of the medicines which will be
selected after repertorisation of the diagnostic symptoms of ‘Simple and
Mucopurulent Chronic bronchitis’ , to determine therapeutic efficacy of these
medicines in Chronic bronchitis, thereby to evluate the efficacy of
homoeopathic medicines for Chronic bronchitis.
Secondary Objective
I. To determine and verify characteristic symptoms of medicine(s)
used.
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Chronic bronchitis protocol
II. To check the progression to complications.
III. To prevent the relapse.
STUDY DESIGN
3
3.1.
Type of study
It will be an open clinical trial and cases will be enrolled from the General O.P.D.
as and when they come till such time that the target is achieved.
3.2
Approach
The study is designed to prove or disprove the hypothesis stated above. This is
conditional on each study site adhering to the protocol, ensuring quality control
and minimizing loss to follow-up to below 5% and is also subject to the fact that
the studies continue till adequate sample size, specified below, is recruited.
3.3.
Location
The following Institutes/Units have been selected for carrying out the research
study keeping in view the adequacy of the manpower, facilities of Lab
investigations and the willingness of the research personnel at the institute:
I. Regional Research Institute, Guwahati (site code- RI 05)
II. Regional Research Institute, Puri (site code- RI 04)
III. Regional Research Institute, New Delhi (site code- RI 02)
IV. Central Research Institute, Kottayam
(site code- CI 01)
V. Clinical Research Unit, Chennai (site code- CU 01)
VI. Clinical Research Unit, Pondicherry (site code- CU 15)
VII. Clinical Research Unit, Tirupati
3.4
Duration of Study

4 years and 1month

3.5
(site code- CU 04)
(2 years for the study + 2 years for the follow-up + 2months for the
preparation of the concluding report.)
Flow chart of study design
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Chronic bronchitis protocol
5
Chronic bronchitis protocol
Presence of
Patients who present with
cough with scanty or copious
mucoid and tenacious
expectoration for three
months or more for at least
two consecutive years,
Written informed
consent

Cystic fibrosis (E84.-)

Bronchitis, not specified as acute or chronic (J40)

Unspecified chronic bronchitis (J42)

Emphysema (J42)

Other chronic obstructive pulmonary diseases (J44)

Asthma (J45)

Status asthmaticus (J46)
No
exclusion
Yes, register the case and go
for baseline assessment
Selection of medicine within the
14 drugs
Assess the case after 15
days
If no response , go for
investigation ,ESR& Xray
Assess the case if no
improvement
Stannum
metallicum,
Phosphorus,
No
Exclusion ,treat the
case in OPD
Arsenicum album, 1. Silicea,
2. Lycopodium
3. Pulsatilla.
Calcarea carb,
4. Sulphur,
5. Hepar sulph,
Ipecacuanha
6. Bryonia alba,
7.
Carbo vegetables,
Spongia tosta,
Antimonium
tartaricum
8.
Change the prescription
maximum twice from trial
drugs. If no response,
refer the case.
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Chronic bronchitis protocol
4.
SELECTION AND ENROLMENT OF PATIENTS
Patients presenting with constant cough with excessive tracheobronchial mucoid or
mucopurulent expectoration for at least 3 months of the year for more than 2
consecutive years will be prescribed pre-selected medicine for a specific period, in a
specified potency and posology. The periodic follow-up and assessment of these
cases will be made for 2 years, at prescribed intervals. It will depend on the changes
observed in the frequency, duration and intensity of the paroxysms of cough,
expectoration, dyspnoea and crackles, as also on the changes observed in the PFT
and the X-ray chest. Various aspects of the study treatment are highlighted below:
Patients presenting with constant cough with excessive tracheobronchial mucoid or
mucopurulent expectoration for at least 3 months of the year for more than 2 consecutive
years will be prescribed pre-selected medicine for a specific period, in a specified potency
and posology. The periodic follow-up and assessment of these cases will be made for 2
years, at prescribed intervals. It will depend on the changes observed in the frequency,
duration and intensity of the paroxysms of cough, expectoration, dyspnoea and crackles, as
also on the changes observed in the PFT and the X-ray chest. Various aspects of the study
treatment are highlighted below:
4.1.
Diagnosis: 1,4
4.1.1
Symptoms,
4.1.2

Patients who present with cough with scanty or copious mucoid
and tenacious expectoration for three months or more for at
least two consecutive years, in absence of a disease that could
account for this symptom;

Recurrent attacks of productive cough, usually in winter months,
with steady increase in severity and duration in successive
years until cough is present the year round.

Shortness of breath and/or a feeling of tightness in the chest
that is worse by exertion or mild physical activity.
Signs

4.1.3
Normally resonant Chest percussion note; and on auscultation,
coarse ronchi (crackles) and wheezes that change in location
and intensity after a deep and productive cough.
Investigations:
 Normal Spirometry:

FEV1: > 80% predicted

FEV1/FVC > 0.7

Vital capacity, mildly diminished,

Maximum expiratory flow rates , invariably low;

Roentgenographic (X-ray) features:

Thickened bronchial walls manifested by tubular or
“tramline” shadows
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Chronic bronchitis protocol
4.2.

A generalized increase in bronchovascular markings.

Pathological investigations

Haemogram, ESR

Sputum for AFB on three consecutive days (to rule out
mycobacterium tuberculosis infection).
Inclusion criteria:
1. Diagnosed cases of Chronic Bronchitis as mentioned in
(4.1) without any complications, from any sex and between
20 and 50 years of age fulfilling the following requirements:
4.3.

Willing to participate in the study and willing to come
for the follow-up visits for two years at prescribed
intervals,

Residing within approachable distance from the
center,

Cases who are not, currently, on any other
treatment, including homoeopathy,

With cases who have taken any treatment, at least
two-weeks’ treatment-free interval should have
lapsed before the screening phase.
Exclusion criteria:
1. Subjects currently on any other treatment (Homoeopathy or
other systems)
2. Subjects who have discontinued treatment less than two
weeks before,
3. Chronic bronchitis, NOS(J42) and obstructive(J44) as per
ICD 10
4. Subjects suffering from Emphysema, cor Pulmonale,
Bronchial asthma, Bronchiectasis, Active pulmonary
tuberculosis (open), Cystic fibrosis, Bronchopulmonary
mycosis, Central airflow obstruction, Acute bronchitis,
Pneumonia, Pulmonary thrombo-embolism, Left ventricular
failure, Pulmonary hypertension, Chronic respiratory failure,
Spontaneous pneumothorax, Bronchogenic carcinoma.
5. Persons requiring oxygen therapy and hospitalization;
6. Cough due to some other underlying disease.
7. FEV,: < 80% PREDICTED
8. FEV1 / FVC < 0.7
5.
STATISTICAL PLAN
5.1.
Sample size:
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Chronic bronchitis protocol

5.2

75 cases per year per centre for two years (keeping also a
margin for the drop-out cases)

909 cases will be sufficient to assess outcome of improvement
rate of 70% with absolute error of ±5% and with a confidence
level of 95%.
Statistical analysis

6.
1050 cases will initially be enrolled in the study.
data obtained during the study would be analysed using appropriate
statistical methods.
Procedures for selection of medicine
6.1. Selection of the medicine:
The selection of the drugs has been arrived at by
repertorising the symptoms due to the Chronic
Bronchitis. [2]. The repertorisation was done using
the Complete Repertory as the reference book.
Considering the fact that the study pertains to the
Chronic Bronchitis , the drugs given in the first
grade (3 points) followed by those in the second
grade (2 points) mentioned against the rubrics
“Chest; inflammation; Bronchial tubes” and
‘Chronic cough’ in the Complete Repertory have
been short-listed. To further minimize the variables,
the specific prescribing symptoms of each of these
drugs have also been worked out after
repertorisation of all the relevant rubrics.
9
Chronic bronchitis protocol
6.1.1 The signs and symptoms of ‘Chronic Bronchitis’
DEFINITIONS
1,4
:
EXAMINATION
INVESTIGATIONS
Chronic bronchitis is a
condition associated with
excessive
tracheobronchial mucus
production sufficient to
cause cough with
expectoration for at least
3 months of the year for
more than 2 consecutive
years.
The patient with
predominant bronchitis is
often overweight and
cyanotic. There is
apparently no apparent
distress at rest, the
respiratory rate is normal or
only slightly increased, and
there is no apparent usage
of accessory muscles.
Spirometry: Normal.
 FEV1: > 80%
predicted
 FEV1/FVC > 0.7
 TLC is often
normal
 A moderate
elevation of RV
 Vital capacity,
mildly diminished
 Maximum
expiratory flow
rates, invariably
low
Simple Chronic bronchitis
describes a condition
characterized by mucoid
sputum production.
Chest percussion note is
normally resonant, and by
auscultation one can usually
hear coarse ronchi and
wheezes that change in
location and intensity after a
deep and productive cough.
Roentgenographic
features:
1. Thickened
bronchial walls
manifested by
tubular or
“tramline”
shadows and
2. A generalized
increase in
bronchovascul
ar markings.
Chronic mucopurulent
bronchitis is characterized
by persistent or recurrent
purulence of sputum in the
absence of localized
suppurative diseases such
as bronchiectasis.
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Chronic bronchitis protocol
Chronic obstructive pulmonary disease (COPD) has
been defined by the Global Initiative for Chronic
Obstructive Lung Disease (GOLD) as a disease
state characterized by airflow limitation that is not
fully reversible (http://www.goldcopd.com). COPD
includes
1. Emphysema, an anatomically defined
condition characterized by destruction and
enlargement of the lung alveoli;
2. Chronic bronchitis, a clinically defined
condition with chronic cough and phlegm;
and
3. Small airways disease, a condition in which
small bronchioles are narrowed.
COPD is present only if chronic airflow obstruction
occurs; chronic bronchitis without chronic airflow
obstruction is not included within COPD.
The patient with chronic bronchitis with obstruction
has a long history of cough and sputum production
with a later onset of wheezing, whereas the asthma
patient with chronic obstruction gives a long history
of wheezing with later onset of chronic productive
cough.
The patient with predominant bronchitis usually has
an impressive history of cough and sputum
production for many years with an immodest history
of cigarette smoking. Initially the cough is present
only in winter months, and the patient is apt to seek
medical attention, if at all, only during the more
severe of the frequent mucopurulent relapses. Over
the years the cough progresses from hibernal to
perennial and mucopurulent relapses increase in
frequency, duration and severity. After beginning to
experience exertional dyspnoea, the patient often
seeks medical help and will be found to have a
severe degree of obstruction.
The development of exertional dyspnoea, often
described as increased effort to breathe, heaviness,
air hunger, or gasping, can be insidious.
History, physical examination, and chest radiographs should be supplemented by
tests of lung function performed during a symptomatically stable period.
Ideally, complete spirometry, plethysmographic lung volumes, transfer of CO,
arterial blood gases, and lung elastic recoil properties should be measured.
11
Chronic bronchitis protocol
6.1.2 Corresponding Rubrics in the Complete Repertory: 5
Symptom
Corresponding Rubrics
Chronic bronchitis is a condition associated with
excessive tracheobronchial mucus production
sufficient to cause cough with expectoration for at
least 3 months of the year for more than 2
consecutive years.
Chest; inflammation; Bronchial tubes
Simple Chronic bronchitis describes a condition
characterized by mucoid sputum production.
Expectoration; mucous
Expectoration; copious; chronically
Expectoration; copious; paroxysmal cough,
after
Expectoration; mucous; translucent
Expectoration; frothy
Expectoration; easy
Expectoration; transparent
Expectoration, white
Expectoration; difficult
Chronic mucopurulent bronchitis is characterized
by persistent or recurrent purulence of sputum in
the absence of localized suppurative diseases
such as bronchiectasis.
Expectoration; purulent
Expectoration; yellow
Expectoration; thick
Expectoration; lumpy
Expectoration; balls, in shape of
Chronic bronchitis, a clinically defined condition
with chronic cough and phlegm.
Cough; chronic
Expectoration; constant, almost day and
evening
The patient with chronic bronchitis with
obstruction has a long history of cough and
sputum production with a later onset of wheezing,
whereas the asthma patient with chronic
obstruction gives a long history of wheezing with
later onset of chronic productive cough.
Expectoration; frequent
Respiration; difficult; cough; with
12
Chronic bronchitis protocol
The patient with predominant bronchitis usually
has an impressive history of cough and sputum
production for many years with an immodest
history of cigarette smoking. Initially the cough is
present only in winter months, and the patient is
apt to seek medical attention, if at all, only during
the more severe of the frequent mucopurulent
relapses. Over the years the cough progresses
from hibernal to perennial and mucopurulent
relapses increase in frequency, duration and
severity. After beginning to experience exertional
dyspnoea, the patient often seeks medical help
and will be found to have a severe degree of
obstruction.
Cough, winter
Respiration; difficult; exertion, after
The development of exertional dyspnoea, often
described as increased effort to breathe,
heaviness, air hunger, or gasping, can be
insidious.
The patient with predominant bronchitis is often
overweight and cyanotic. There is apparently no
apparent distress at rest, the respiratory rate is
normal or only slightly increased, and there is no
apparent usage of accessory muscles.
No rubric taken
Chest percussion note is normally resonant, and
by auscultation one can usually hear coarse
ronchi and wheezes that change in location and
intensity after a deep and productive cough.
No rubric taken
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Chronic bronchitis protocol
6.1.3 RUBRICS TAKEN FOR REPERTORISATION:5
1.
Chest; inflammation; Bronchial
tubes
2.
Cough; chronic
3.
Expectoration; copious;
chronically
4.
Cough, winter
5.
Expectoration; constant, almost
day and evening
6.
Expectoration; copious;
paroxysmal cough, after
7.
Expectoration; frequent
8.
Respiration; difficult; cough;
with
9.
Expectoration; mucous
10.
Expectoration; mucous;
translucent
11.
Expectoration; frothy
12.
Expectoration; easy
13.
Expectoration; transparent
14.
Expectoration, white
15.
Expectoration; purulent
16.
Expectoration; difficult
17.
Expectoration; yellow
18.
Expectoration; thick
19.
Expectoration; lumpy
20.
Expectoration; balls, in shape
of
21.
Respiration; difficult; exertion,
after
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Chronic bronchitis protocol
19/12
19/11 Carb-v.
17/10
17/9
17/8
16/8
3
3
2
3
2
2
3
3
3
02
0
0
1
2
1
1
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1
0
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3
3
3
3
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0
3
3
0
0
2
3
0
3
3
0
0
0
34/16
30/13
28/14
26/11
24/11
25/12
20/9
18/15
19/10
17/11
15/9
15/7
14/10
14/9
11/7
12/7
12/6
13/7
Chin
20/9
3
Dros.
20/11
2
Spong.
20/12
2
Dulc.
22/11
3
Ant-t
24/18
3
Caust.
25/11
3
Bry
29/14
Ip.
29/14
3
Hep.
Phos
34/14
3
Calc.
Sil.
35/17
3
Puls.
Ars.
36/15
01
Lyc.
Stann.
40/18
Sulph.
6.1.4 Repertorisation chart (using Complete Repertory By Roger van
Zandvoort: 5
04
2
1
0
0
0
0
0
0
0
1
1
0
1
0
1
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3
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1
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1
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3
3
3
3
3
3
3
1
3
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2
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3
3
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0
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1
0
0
0
0
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11
0
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3
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2
2
2
3
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1
0
1
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1
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1
0
0
0
0
1
14
2
2
1
3
3
2
2
2
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1
1
2
1
2
1
2
0
1
15
2
2
3
3
3
2
3
1
1
1
1
0
2
1
1
0
2
3
16
3
2
0
2
2
3
2
1
2
3
1
3
1
0
2
1
1
1
17
3
2
3
3
3
3
3
2
3
1
2
1
0
2
0
2
2
0
18
2
2
3
1
2
2
2
1
3
1
1
2
1
1
2
0
0
0
19
2
2
3
1
1
1
0
1
2
0
1
0
0
1
0
1
0
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20
3
0
2
0
1
0
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1
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0
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21 2
3
2
2
3
2
3
2
0
3
0
0
0
2
0
3
0
0
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Chronic bronchitis protocol
19/11 Carb-v.
Spong.
19/12
2
3
3
3
3
2
3
2
0
0
1
2
1
1
0
1
0
0
0
2
0
2
3
3
3
3
3
1
0
3
3
0
0
2
0
3
0
34/16
30/13
28/14
26/11
24/11
25/12
20/9
18/15
19/10
17/11
15/9
14/10
14/9
12/7
17/9
20/11
Ant-t
20/12
2
Bry
22/11
Ip.
24/18
3
Hep.
25/11
Sulph.
29/14
3
Calc.
29/14
3
Puls.
34/14
3
Lyc.
35/17
3
Phos
36/15
3
Sil.
40/18
1
Ars.
s.no.
Stann.
6.1.5.-useful remedies5
4
2
1
0
0
0
0
0
0
0
1
1
1
0
0
5
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6
0
0
0
0
0
0
0
1
0
0
0
0
0
0
7
2
0
1
0
1
2
0
1
1
0
0
0
0
0
8
3
3
2
3
2
0
1
1
2
3
1
3
2
1
9
3
3
3
3
3
3
3
1
3
1
3
2
2
2
10
0
3
1
0
0
0
0
0
0
0
0
0
0
0
11
0
3
1
2
0
2
1
1
1
1
1
1
0
0
12
3
0
1
0
0
2
0
1
1
1
0
1
1
0
13
2
2
2
3
0
1
0
1
0
0
1
1
0
0
14
2
2
1
3
3
2
2
2
0
1
1
1
2
2
15
2
2
3
3
3
2
3
1
1
1
1
2
1
0
16
3
2
0
2
2
3
2
1
2
3
1
1
0
1
17
3
2
3
3
3
3
3
2
3
1
2
0
2
2
18
2
2
3
1
2
2
2
1
3
1
1
1
1
0
19
2
2
3
1
1
1
0
1
2
0
1
0
1
1
20
3
0
2
0
1
0
0
1
0
0
0
0
0
0
21
2
3
2
2
3
2
3
2
0
3
0
0
2
3
16
Chronic bronchitis protocol
6.1.6 Trial medicines
The following drugs will be tried during the study:
Stannum metallicum,
Phosphorus,
Calcarea carb,
Ipecacuanha
Carbo vegetables,
Arsenicum album,
2. Lycopodium
4. Sulphur,
6. Bryonia alba,
Spongia tosta,
1. Silicea,
3. Pulsatilla.
5. Hepar sulph,
7. Antimonium tartaricum
8.
6.1.7 Prescribing indications of the medicines on trial
No. MEDICI RUBRICS
NE
01.
Stannu
m
metallic
um
(40/16)
Chest; inflammation; Bronchial tubes
Expectoration; copious; chronically
Respiration; difficult; cough; with
Expectoration; mucous
Expectoration; easy
Expectoration; difficult
Expectoration; yellow
Expectoration; balls, in shape of
Cough, winter
Expectoration; frequent
Expectoration; transparent
Expectoration, white
Expectoration; purulent
Expectoration; thick
Expectoration; lumpy
Respiration; difficult; exertion, after
6
CHARACTERISTIC
SYMPTOMS
It is especially suited to persons
who have long been g rowing
feeble. There is increasing
weakness, cachexia with : sallow
waxy countenance and dark
rings under the eyes.
Pain begins lightly and increases
gradually to the highest point and
then gradually declines in the
same manner as it appeared.
There is GREAT DEBILITY and
profound weakness which is the
key note of Stannum. It is
marked both mentally and bodily.
The chest is so weak that she
drops into a chair instead of
sitting down.
Feels weak and faints especially
when going downstairs. Can go
up well enough. Nausea and
vomiting from the odour of
cooking food.
Empty, sinking all-gone
sensation in chest and stomach
Sweetish and salty expectoration
and taste in mouth.
The patient experiences very
debilitating sweat after 4 a.m.
The patient is sad, despondent,
feels like crying all the time, but
crying makes her worse.
Yellowishness is the nature of
17
Chronic bronchitis protocol
discharges.
Mentally the patient is very much
sad and despondent.
Great sadness strong
disinclination to talk and a
pronounced aversion to the
company of men.
Continued restlessness with
anxiety.
Distress of mind ceases as soon
as menses begin to flow.
Mental symptoms are caused by
emotion, fright, etc.
02.
Arsenicu
m album
(37/16)
Chest; inflammation; Bronchial tubes
Expectoration; copious; chronically
Respiration; difficult; cough; with
Expectoration; mucous
Expectoration; mucous; tanslucent
Expectoration; frothy
Respiration; difficult; exertion, after
Expectoration; transparent
Expectoration, white
Expectoration; purulent
Expectoration; difficult
Expectoration; yellow
Expectoration; thick
Expectoration; lumpy
Expectoration; balls, in shape of
Cough, winter
The patient is lean, thin,
debilitated having Hippocratic
face dirty and waxy look of the
skin .
Very fastidious. \wants
everything neat, clean and in
order.
Chilly patient. There is
internal chilliness and so the
patient craves heat, excepting
in outer head.
Arsenic patient has GREAT
FEAR OF DEATH.
Mentally restless, but
physically too
weak and exhausted to move
about.
Burning pain relieved by heat
except in head.
Great prostration is
persistently present, sinking of
strength out of proportion to a
degree of illness.
Gastric derangements such
as diarrhoea, vomiting, etc.,
are due to food poisoning
from spoiled eggs, fish or
meat, decayed food, alcohol,
ice cream, etc.
Complaints return periodically
(usually annually)
All discharges are acrid,
scanty, putrid, dark and
offensive with cadaverous
odour
Thirst for small quantity of
water at short intervals in
acute states but in chronic
state there is no thirst.
Cannot bear the smell or sight
of food.
18
Chronic bronchitis protocol
All symptoms are aggravated
at MID-DAY AND MIDNIGHT.
03.
Silicea
(35/17)
Chest; inflammation; Bronchial tubes
Expectoration; copious; chronically
Expectoration; mucous
Expectoration; purulent
Expectoration; yellow
Expectoration; thick
Expectoration; lumpy
Expectoration; balls, in shape of
Respiration; difficult; cough; with
Expectoration; transparent
Respiration; difficult; exertion, after
Cough; chronic
Expectoration; frequent
Expectoration; mucous; tanslucent
Expectoration; frothy
Expectoration; easy
Expectoration; white
Very nervous, excitable
temperament. Lack of stamina
and very much afraid of failure.
Very sensitive to all
impressions. WANT OF GRIT,
both mental and physical.
Fixed ideas. Has got pin mania,
especially for babies. Thinks of
nothing except pins; he fears
them, still searches for them
and counts and preserves
them with great care.
Headstrong and obstinate
babies who cry when kindly
spoken to.
Ailments from: Vaccination,
suppressed foot-sweat,
exposure to draught of air.
Chest complaints of stone
cutters.
Highly Chilly patient. Wraps
himself up with warm clothing
even in hot summer weather.
Every little injury suppurates.
Has got a wonderful CONTROL
OVER THE SUPPURATIVE
PROCESSES, anywhere and
everywhere in the body.
Constitution which suffers from
deficient nutrition from
defective assimilation.
Very sensitive to all impressions,
especially noise and becomes
anxious there from.
Obstinate constipation; stool
hard and knotty. When
PARTLY EXPELLED
RECEDES BACK.
Night-walking. Gets up while
asleep, walks about and lies
down again – all quite
unconsciously.
Desire for cold drinks, cold food,
ice cream. Wants to be
magnetized.
Sweat of hands, toes, feet,
axillae is VERY OFFENSIVE.
19
Chronic bronchitis protocol
Intolerable, sour, carrion-like
odour of feet, without
perspiration and every
evening.
04.
Phosph
orus
(34/14)
Chest; inflammation; Bronchial tubes
Expectoration; copious; chronically
Respiration; difficult; cough; with
Expectoration; mucous
Expectoration; transparent
Expectoration, white
Expectoration; purulent
Expectoration; yellow
Cough; chronic
Expectoration; frothy
Expectoration; difficult
Respiration; difficult; exertion, after
Expectoration; thick
Expectoration; lumpy
Phosphorus is best suited for tall,
slender persons with narrow
chest. Young people who grow
too rapidly and are incline to
stoop.
Sanguine temperament,
possessing quick perception and
very sensitive nature; also
having bilious, irritable
temperament.
Chilly patient, its head and
stomach crave cold, cold
application, cold food and COLD
DRINKS.
Burning anywhere and
everywhere all over the body.
Burning in spots along the spine,
between the scapulae, of palm
and hands, in chest.
A weak, empty all gone
sensation in head, chest,
stomach and entire abdomen.
Craving cold thins, ice-creak
which agrees; cold water which
is thrown up as soon as it gets
warm in the stomach. Aversion
to tobacco, sweets tea, pudding,
coffee and beer.
Oversensitiveness. Light, noise,
odour, touch, electric changes,
thunderstorms.
Disinclination to both mental and
physical exertion even to study
or to converse.
Restlessness. Cannot stand still
for a moment, with CONSTANT
FIDGETY FEELING ALL OVER
BODY, especially in evening, at
twilight. Restlessness with
anxiety.
Most of the complaints are
aggravated when lying on left
side.
Swelling of both the eyelids.
Mind. The patient is very much
apathetic and indifferent to
friends and surroundings,
unwilling to talk, thinks slowly,
moves sluggishly.
20
Chronic bronchitis protocol
05
Lycopod
ium
(29/14)
Chest; inflammation; Bronchial tubes
Expectoration, white
Expectoration; purulent
Respiration; difficult; exertion, after
Expectoration; mucous
Expectoration; yellow
Respiration; difficult; cough; with
Expectoration; difficult
Expectoration; thick
Cough; chronic
Expectoration; copious; chronically
Expectoration; frequent
Expectoration; lumpy
Expectoration; balls, in shape of
Patient is quite intelligent, but
physically weak. There is great
fear in darkness. Fear of death
when alone.
Mental exertion, strong emotion,
strong odours, gas vapours,
thunderstorm, lightning, loss of
vital fluids, exposure to
drenching rain, tobacco by
washing clothes, having hair cut;
excessive use of table salt
Patient is tired; Chronic mental
fatigue.
Dread of appearing in public.
Desire to be alone; yet has
dread of solitude.
Great anticipation: lack of
confidence, weakness of
memory; confused thoughts;
loss of confidence in himself.
Easily angered; cannot endure
opposition or contradiction.
Seeks dispute.
Greedy and miserly, malicious,
avaricious and pusillanimous;
very much sensitive; even cries
when thanked.
FOR PERSONS
INTELLECTUALLY KEEN BUT
PHYSICALLY WEAK.
Ailments from: Fright, anger,
mortification or vexation with
reserved displeasure.
RIGHT SIDED REMEDY.
Suited for deep, chronic,
progressive diseases.
Nearly all the diseases are
WORSE IN THE AFTERNOON
4 TO 8 PM.
Sourness of the discharges.
Everything tastes sour, e.g.
eructation. Heartburn,
waterbrash, sour vomiting.
Intolerance of cold drinks;
craves everything warm.
Desire for sweet things:
warmfood and drink.
Aversion to tobacco, bread,
coffee.
Canine hunger, but a few
mouthfuls fill up to the throat.
Acidity, wine and bloating of
abdomen, especially the lower
21
Chronic bronchitis protocol
abdomen.
Red sand in urine. Child cries
before urinating.
Fan like movement of alaenasi.occuring in cerebral and
abdominal complaints.
Half open condition of the eyes
during sleep.
Right foot hot and left cold.
Dryness of parts such as vagina
and skin especially palms.
06.
Pulsatill
a
(29/14)
Chest; inflammation; Bronchial tubes
Expectoration; copious; chronically
Respiration; difficult; cough; with
Expectoration; mucous
Expectoration; easy
Expectoration; difficult
Expectoration; yellow
Expectoration; balls, in shape of
Cough, winter
Expectoration; frequent
Expectoration; transparent
Expectoration, white
Expectoration; purulent
Expectoration; thick
Expectoration; lumpy
Respiration; difficult; exertion, after
The patient is mild, gentle,
amiable in character, yielding
disposition, but sometimes timid
too.
Changeability of mental
conditions runs through the
whole drug.
Weeping disposition. The patient
is always full of tears. So she
cannot relate her complaints
without weeping.
Hypochondriacal moroseness;
takes bad side of everything.
Consolation: gives her immense
comfort and relief.
Highly emotional, afraid in the
evening, fears to be alone. Fear
of darkness and of ghosts.
Morbid fear of meeting the
opposite sex.
Ailments from: Chill getting feet
wet; eating fatty and starchy
food; ice cream; tea and coffee,
abuse of mercury, quinine,
sulphur, chamomile, abortion,
irregular menses; ovarian and
uterine troubles; worm affection
in children and indigestion.
07.
Calcare
a Carb.
(26/12)
Expectoration; copious; chronically
Expectoration; mucous
Expectoration; purulent
Changeability of symptoms.
Chilliness.
Thirstlessness.
Desire: for open air, fatty food.
Disagrees meat, bread, milk and
smoking.
Aggravation from warm in
general and amelioration from
cold in general and from open
air.
Great apprehension, worsening
towards evening.
Fear of darkness, loss of reason,
22
Chronic bronchitis protocol
Expectoration; yellow
Respiration; difficult; exertion, after
Chest; inflammation; Bronchial tubes
Expectoration, white
Expectoration; difficult
Expectoration; thick
Respiration; difficult; cough; with
Expectoration; frothy
Expectoration; balls, in shape of
misfortune, contagious and
chronic disease. Fears that she
will lose her reason or that
people will observe her mental
confusion. Very forgetful,
confused and low spirited.
Dejected and melancholic.
Great anguish with palpitation.
Restlessness of mind with
gloomy mood and anxiety.
Peevish, always obstinate and
self-willed. Indisposed to all
work. Sight mental effort
produces heat. Timid and
restless, as if an evil was
impending over her. Solitude is
a burden to her with coldness
of face, of hands and feet.
Great desire to be magnetized.
Ailments from: Defective
assimilation, imperfect
ossification, suppressed sweat,
alcohol, cold moist wind, selfabuse, over lifting, strains,
mental strains. Loss of vital
fluids, suppressed eruption,
suppressed menses,
Suppressed foot-sweat, fright,
etc.
GREAT SENSITIVENESS TO
TAKE COLD; CANNOT
TOLERATE COLD.
Disposed to grow fat.
HEAD SWEATS PROFUSELY,
WHILE SLEEPING WETTING
the pillow far around. Sweat of
single parts, Sour Smelling.
Coldness in general and the
single part.
Feels better in every way when
constipated.
Likes to be magnetized.
All discharges smell sour.
Longing for eggs, craves
undigestible things; has
aversion to meat; great longing
for fresh air.
08.
Sulphur
(25/18)
Expectoration; copious; chronically
Chest; inflammation; Bronchial tubes
Expectoration, white
Sulphur is especially suited to
lean, stoop-shouldered persons
who walk and sit stooping, walk
stooping like an old man.
23
Chronic bronchitis protocol
Expectoration; yellow
Respiration; difficult; exertion, after
Cough; chronic
Expectoration; copious; paroxysmal
cough, after
Expectoration; frequent
Respiration; difficult; cough; with
Expectoration; mucous
Expectoration; frothy
Expectoration; easy
Expectoration; transparent
Expectoration; purulent
Expectoration; difficult
Expectoration; thick
Expectoration; lumpy
Expectoration; balls, in shape of
9.
Hepar
sulph(25
/12)
Chest; inflammation; Bronchial tubes
Expectoration; mucous
Expectoration; yellow
Expectoration; thick
Expectoration; frequent
Respiration; difficult; cough; with
Expectoration; thick
Expectoration; lumpy
Expectoration; difficult
Expectoration frothy
Expectoration; easy
Expectoration; purulent
10.
Ipecacu
anha
(20/12)
Chest; in Chest; inflammation;
Bronchial tubes
Respiration; difficult; cough; with
Expectoration; difficult
STANDING IS THE WORSE
POSITION FOR A SULPHUR
PATIENT.
Dirty, filthy look of the body,
prone to skin affections have
redness of all the external
orifices.
Patient is very much sensitive to
atmospheric changes. He is
accepted as a HOT PATIENT.
GREAT IRRITABILITY,
OVERSENSITIVENESS AND
HYPERSENSITIVENESS.
Suited to torpid lymphatic
constitution, persons with light
hair and complexion; muscles
are soft and flabby. Irritable
temperament: easily excited,
slightest cause irritates the
patient. Highly chilly patient.
Very sensitive to touch.
HYPERSENSITIVENESS to
touch.
Sweat profusely day and night
without any relief, which is sour
and offensive.
Sensation of a splinter, fish bone
or plug in throat.
All the discharges are very much
sour.
Aggravation From COLD IN
GENERAL, cold air, cold food,
uncovering. Amelioration: From
WARMTH IN GENERAL;
covering from head to foot, from
warm food and drink; IN DAMP
WET WEATHER.
The patient has great CRAVING
for sour things, vinegar, wine,
acids and strong tasting foods.
AVESION to fatty food;
dislike for all kinds of
nourishment
Most of its acute complaints
commence with nausea and
vomiting or all complaints
requiring Ipecac are attended
24
Chronic bronchitis protocol
Respiration; difficult; exertion, after
Cough, winter
Expectoration; mucous
Expectoration frothy
Expectoration; easy
Expectoration, white
Expectoration; purulent
Expectoration; yellow
Expectoration; thick
11.
Bryonia
(16/13)
Chest; inflammation; Bronchial tubes
Expectoration; mucous
Expectoration; copious; chronically
Cough, winter
Respiration; difficult; cough; with
Expectoration; frothy
Expectoration; transparent
Expectoration, white
Expectoration; purulent
Expectoration; difficult
Expectoration; yellow
Expectoration; thick
Expectoration; lumpy
more or less with nausea.
Nausea constant, continuous
and persistent with or without
vomiting. Nausea not relieved by
vomiting.
Thirstlessness runs through the
whole drug. Clean tongue, with
much saliva, but no thirst.
Bright red haemorrhage from
natural orifices like nostrils,
mouth and especially from
uterus.
Cold sweat on forehead
Desire for sweets and dainties.
Tall slender persons having dark
hair, dark complexion, and firm
muscular fibres.
Irritable temperament.
Patients are hot; aggravated by
warmth in general.
Rheumatic and gouty diathesis.
All complaints are worse from
motion. WITH AMELIORATION
BY ABSOLUTE REST AND
PRESSURE.
It is a very persistent remedy. All
complaints develop slowly and
have an insidious beginning.
Bryonia causes dryness of all the
mucus membranes e.g. lips,
mouth, nose, respiratory tract,
alimentary tract and thereby.
Great thirst for large quantity of
cold water at long intervals; great
appetite, eats varaciously.
Stitching pain runs through the
whole of Bryonia which is
relieved by absolute rest and
pressure and by lying on painful
side.
Dropsical effusion into the
serous and synovial
membrerane, resulting in
pleurisy, rheumatic arthritis etc.
Desires for things, which when
offered are immediately refused.
Oysters, sweets, coffee, cold
acid drinks and sour drink. To
milk, rich food, fatty and greasy
food.
Most complaints aggravate in
summer and by heat; symptoms
aggravate after a meal.
There is intolerance of vegetable
food.
25
Chronic bronchitis protocol
12.
Antim
tart
(16/11)
Chest; inflammation; Bronchial tubes
Respiration; difficult; cough; with
Cough; chronic
Expectoration; mucous
Expectoration; purulent
Cough, winter
Expectoration; frothy
Expectoration; easy
Expectoration; transparent
Expectoration, white
Expectoration; difficult
Expectoration; thick
Nose-bleed when menses
should appear; blood-spitting or
haemoptysis.
Breasts are heavy, of a stony
hardness, pale but hard, hot and
painful; MUST SUPPORT THEM
WITH HAND TO prevent least
motion.
Mind. The patient is very
morose and ill-humoured;
exceedingly irritable and inclined
to be angry. There are great
anxiety and mental depression.
Delirium, talks about daily
business; worse at night; desires
to escape from bed and wants to
go home, although the patient is
at home. Constant motion of the
left arm and leg. Desires for
things which are refused when
offered. Weakness of mind, as if
the would faint.
Ailments from - Anger, chagrin,
mortification; complaints after
taking cold or getting hot in
summer; when the days are hot
and nights are cold; cold food
and drink; from suppression of
discharges and skin eruptions.
Hydrogenoid constitution .
Usually suited for diseases
originating from exposure to
damp basements or cellars, and
after vaccination.
There is great accumulation of
mucus in air passage which
cannot be coughed out, but gives
a rattling sound, popularly known
as “Death Rattle”.
Face become pale, cyanosed
and flushed due to circulation of
unoxydised blood.
Nausea. Vomiting, coldness and
prostration run through.
IRRESISTIBLE DESIRE TO
SLEEP.
Craving for apples and acids.
Aversion to mild and tobacco.
Pneumonia with jaundice.
Bad effects of vaccination, when
Thuja fails and Silicea.
Pustular eruption like small pox
is a great symptoms.
Mind. Confusion of head with a
feeling as if he must sleep. Child
26
Chronic bronchitis protocol
14
Carbo
vegetabi
lis(20/11
)
Expectoration; copious; chronically
Chest; inflammation; Bronchial tubes
Respiration; difficult; cough; with
Expectoration; mucous
Expectoration, white
Expectoration; yellow
Respiration; difficult; exertion, after
Expectoration; easy
Expectoration; purulent
Expectoration; thick
Expectoration; lumpy
will not allow ilself to be touched.
Bad humour during bronchial
catarrh. Apprehension and
restlessness during evening.
Dread of being left alone. Mental
excitement and nervousness.
The patient is frightened at night.
Vertigo on closing the eyes,
when walking and flickering
before the eyes.
Persons of advanced age,
women at turn of life;
prematurely old people.
Cachetic persons, young or old.
The face is puffy, bluish, pale
and Hippocratic with cold sweat.
Though the body is cold to touch,
the patient WANTS constantly
ato be FANNED RAPIDLY AND
FROM NEAR.
HAEMORRHAGIC DIATHESIS.
Passive haemorrhage of black or
dark blood from every orifice of
the body e.g. bleeding from lung,
bladder, uterus, stomach, ulcers,
etc. resulting from weakened
circulation. Haemorrhagic
tendency runs through the whole
remedy.
Exhausted vitality from loss of
vital fluid.
Surface of the body is COLD TO
TOUCH, especially from knee to
feet. The pulse is intermittent,
thready and imperceptible.
Weak Digestion, SIMPLE FOOD
DISAGREES causing excessive
flatulence; abdomen is full to
bursting point especially on the
upper part; aggravation from
least food and relief from
eructation and on passing flatus.
In the last stage of any disease
with copious cold sweat, cold
breath, cold tongue, voice lost,
this remedy may save a life.
WANTS TO BE FANNED
RAPIDLY AND FROM A CLOSE
DISTANCE in nearly every
complaint.
Wants clothing loose around the
abdomen.
The patient craves, things which
makes him sick. Whisky or
brandy.
27
Chronic bronchitis protocol
Hoarseness aggravated in the
evening.
Sump toms of imperfect
oxidation, resulting from deficient
capillary circulation, causing
blueness of skin and coldness of
extremities.
Constant sour and rancid
eructation.
Slowness of though and
weakness of memory, dislikes
darkness and fears ghosts.
Loss of vital fluid, memory, salt,
salted meat or fish from abuse of
quinine, especially suppressed
chill and fever; bad effects of
long ago injury, persons who
have never fully recovered from
the bad effects of some previous
illness.
14.
Spongia
(14/08)
Chest; inflammation; Bronchial
tubes
Respiration; difficult; exertion,
after
Cough; chronic
Expectoration; mucous
Expectoration, white
Expectoration; yellow
Respiration; difficult; cough; with
Expectoration; difficult
Expectoration; lumpy
Exhaustion and heaviness of the
body after slight exertion, with
orgasm of blood to chest, face.
Anxiety and difficult breathing.
Anxiety and fear. Every
excitement increases the cough.
Great dryness of all airpassages. Hoarseness; larynx
dry, burns, constricted. Cough,.
Dry barking, croupy; larynx
sensitive to touch. Croup;
worse, during inspiration and
before midnight. Respiration
short, panting, difficult; feeling of
a plug in larynx. Cough abates
after eating or drinking,
especially warm drinks.
Chest weak; can scarcely talk.
Bronchial catarrh, with wheezing,
asthmatic cough, worse cold air,
with profuse expectoration and
suffocation; worse, lying with
head low and in hot room.
Oppression and heat of chest,
with sudden weakness.
28
Chronic bronchitis protocol
Selection of Medicine
Selection of medicine will be made out of the 14 medicines taken up for clinical trial. The first
prescription from amongst these 14 medicines shall be the medicine that fetches the highest
value on repertorisation of t he presenting signs and symptoms of the disease and its selection
shall be further guided by the characteristic mental/emotional and physical attributes of the
patient and concomitant(s), if any.
Cases which need medicine(s)other than trial group of medicines will be treated in the general
OPD and not included in the study. A separate record of such cases will however be maintained
at the center.
6.2.1
In case of chronic state
6.2.1.1
Basis of Selection of Medicine:
Selection of medicine will be made out of the 14 trial medicines, to be guided by the totality of
presenting signs and symptoms on the basis of ‘Principle of Similia’.
A comprehensive case record on the specially evolved case recording proforma will be
maintained Form C1. Care will be taken to record the following:

Detailed evolution of the complaints.

Careful analysis of the characteristic nature of the symptoms
First prescription:
This will constitute of single dose of indicated medicine in potency 30, 4 pills (size
30), to be taken by the patient on empty stomach, and followed by placebo, next day onwards,
three times a day for two weeks.
6.2.1.2
Selection of Potency
This will constitute of single dose of indicated medicine in potency 30, to be
taken by the patient on empty stomach.
6.2.1.3
Dose
Each Dose of indicated medicine will consist of, 4 pills size 30.
6.2.1.4
Repetition
Indicated medicine will not be repeated.
29
Chronic bronchitis protocol
6.2.1.5. Follow up (Change of Medicine / Second Prescription)
Participants will be followed for assessment as per Form D. Response of the prescription will
be assessed and further treatment will be as per following guidelines:
A.
i.
ii.
iii.
iv.
v.
In case of amelioration:
If improvement continues → Placebo to continue.
If improvement stops → Repeat the medicine (first prescription) in the same potency.
If no further amelioration occurs even after medicine given in same potency or improvement lasts for
a very short period → Give higher potency of same medicine.
If amelioration of presenting complaints is accompanied by appearance of old symptoms → continue
placebo till the improvement continues.
If old symptoms come back to stay → repeat same medicine in same potency and then followed as
in (iii) above. In case there is no perceptible improvement after adequate repetition of medicine in
different potencies, change of medicine is to be considered
B. In case of aggravation:
(i)
Increase in baseline symptoms
a. Short aggravation followed by consistent amelioration (homoeopathic
aggravation):→ Continue placebo.
b. Aggravation of same symptoms without any relief:

If intensity is mild → wait for another week, and if no improvement
follows or worsening occurs after one week, change of medicine is to
be considered.

If intensity is severe → the case to be treated as an acute
exacerbation of chronic disease.
(ii)
Appearance of new symptoms
(a)
If new symptoms are mild and do not cause much concern to the
patient → placebo will be continued for one week.
(b)
If no improvement follows or worsening occurs after one week →
change of medicine is to be considered.
(c)
If these new symptoms are severe and cause considerable discomfort
to patient → change of medicine is to be considered.
C. In case of no change after first or subsequent prescriptions:
a)
In case there is no perceptible change (either worse or better) after 1 week of
administration of medicine →one dose of the same medicine to be repeated in higher
potency (200 and 1M in succession whenever no response from 200) 4 pills, size
no.30, taken over the tongue, followed by placebo for one week.
b)
In case there is no perceptible improvement after adequate repetition of medicine in
different potencies, the investigator must look for any obstacle(s) to cure and steps may
be taken to remove them. A record of such advice followed by the patient is to be kept
in the case follow up. In case no such obstacle(s) found, change of medicine is to be
considered on the same line as mentioned in the footnote.
------------------------------------------------------------------------------------------------------------------If aggravation/ no change still continues, another medicine on the basis of modified picture of
the disease is to be considered. In case aggravation continues or no improvement comes up
inspite of changing medicine twice, the case is to be closed from study and declared as clinical
failure
30
Chronic bronchitis protocol
6.2.2
In case of acute exacerbation of chronic disease or any other acute disease arising
during the course of treatment of chronic disease.
6.2.2.1. Basis of Selection of Medicine:
Prescription will be based on the characteristic symptoms modified as a consequence of acute
disease. The medicine selected will be either a continuation of the pre-selected medicine, or
one of the better indicated trial medicine, or a new remedy which may be worked out for acute
totality.
6.2.2.2
Selection of Potency:
Medicine for the treatment of acute exacerbation shall be given in 6 potency.
6.2.2.3
Dose
Each Dose of indicated medicine will consist of, 4 pills size 30.
6.2.2.4
Repetition
Indicated medicine will be repeated few minutes to hours depending on the intensity of the
symptoms till perceptible change appears (Improvement of signs and symptoms). Appearance of
any change will be immediately followed by placebo/ or change in remedy, according to response.
6.2.1.5. Follow up (change of medicine / second prescription)
Follow up will be done frequently (at an interval of 1-3 days) depending on the need, till such
time the acute condition subsides after judicious treatment. Response of the prescription will
be assessed and further treatment will be as per following guidelines:
A.
In case of amelioration of presenting sign & symptoms:
I.
If improvement continues → Placebo to continue.
II.
If improvement stops and case presents with same symptomatology → Repeat the same
medicine (first prescription) in the higher potency. i.e. 30 if needed.
III. If case presents with different symptomatology → change of medicine; another indicated
medicine from amongst Trial Medicines in 6 potency on the same guidelines as for the first
prescription.
B.
In case of aggravation of presenting sign & symptoms:
(i) Increase in baseline symptoms
a) Short aggravation followed by consistent amelioration (homoeopathic aggravation):→
Continue placebo.
b)
(ii)
Aggravation of same symptoms without any relief:

If intensity is mild → wait for few hours’ and if no improvement follows
or worsening occurs, change of medicine is to be considered.

If intensity is severe →To be withdrawn from the study and to be
referred for appropriate medical care.
Appearance of new symptoms
a) If new symptoms are mild and do not cause much concern to the patient →
placebo will be continued.
b)
If no improvement follows or worsening occurs → change of medicine; another
indicated medicine from amongst Trial Medicines in 6 potency on the same
guidelines as for the first prescription.
c)
If these new symptoms are severe and cause considerable discomfort to patient
→ change of medicine; another indicated medicine from amongst Trial Medicines
in 6 potency on the same guidelines as for the first prescription.
d)
If the medicine indicated for change of prescription at any stage does not lies in
the trial group of medicines, the case will excluded from study.
31
Chronic bronchitis protocol
C.
In case of no change after first or subsequent prescriptions:
a) In case there is no perceptible change (either worse or better i.e. change in FDI) on
next day or after few hours of administration of medicine →one dose of the same
medicine in higher potency is to be repeated followed by placebo.
b) In case there is no perceptible improvement after adequate repetition of medicine,[the
investigator must look for any obstacle(s) to cure and steps may be taken to remove
them. A record of such advice followed by the patient is to be kept in the case follow
up. In case no such obstacle(s) are found, change of medicine is to be considered on
the same line as mentioned in the footnote.
Efforts would be made to ensure compliance of Instructions and adherence to the prescribed
therapeutic schedule. In case of deviation, valid justification should be recorded.
Foot note ; If aggravation/ no change in 1 day or early, depending on intensity , another medicine on the
basis of modified picture of the disease is to be considered from 13 trial medicine. In case aggravation
continues or no improvement comes up even after a maximum of three indicated medicines have been
tried and no improvement occurs, the case is to be closed from study and declared as clinical failure.
Such patients will be referred and will be treated according to the practice of the hospital/institute.
Treatment of chronic disease after the acute exacerbation/acute disease subsides is to be made
depending on the state of signs/ symptoms of the chronic disease i.e. the indicated medicine in suitable
potency will be given only on the appearance of the chronic state and placebo to be continued till such
time that there is amelioration of the chronic disease. Case will be followed up as per approach towards
chronic case.
6.2.3.
6.2.4
Source of Medicines for Trial
Homoeopathic medicines for the trial would be procured from the SBL
Private Ltd. Sahibabad, Ghaziabad, Uttar Pradesh.
Change of therapy
The change of therapy or the second prescription shall be made in
accordance with the guidelines mentioned for the second prescription
above(4.5.2.2)
6.2.5
General supportive care
Intelligent management must be based on as complete knowledge as
possible of the degree of obstruction, the extent of disability, and the
relative reversibility of the patient’s illness. After the initial assessment,
the physician has some idea of the relative emphasis to be placed on
patient education, rehabilitative and preventive measures, and direct
therapeutic interventions in management of the patient and the illness.
Smoking
Cigarette smoking is the most commonly identified correlate with both
chronic bronchitis during life and extent of emphysema at postmortem.
Passive exposure to tobacco smoke correlates with respiratory
symptoms such as cough, wheeze, and sputum production.
The physician should always ask the patient about smoking, urge the
patient to stop smoking, help the patient set a date to stop, and
provide close follow up support for the patient’s efforts.
Environment (Air-pollution) & Occupation
The incidence and mortality rates of both chronic bronchitis and
emphysema may be higher in heavily industrialized urban areas.
32
Chronic bronchitis protocol
Exacerbations of bronchitis are clearly related to periods of heavy
pollution with sulfur dioxide (SO2) and particulate matter.
Chronic bronchitis is more prevalent in workers who engage in
occupations exposing them to either inorganic or organic dusts or to
noxious gases. Epidemiological surveys have succeeded in
demonstrating an accelerated decline in lung function in many such
workers --- e.g., workers in plastic plants exposed to toluene
diisocyanate, and carding room workers in cotton mills --- suggesting
that their occupational exposure contributes to their future disability.
In patients in whom occupational or environmental exposures are
thought to play a significant role, change of occupation or relocation of
dwelling is advisable. A simple environmental change is that of
eliminating aerosol sprays such as deodorants, hair sprays, and
insecticides from the household. Hair sprays have been shown to
produce acute airways responses even in normal subjects.
Exercise
Exercise programmes although not accompanied by measurable
improvement in lung function, result in increased exercise tolerance
and an improved sense of well-being. The improvement is usually
task-specific, so most physicians advise walking in preference to the
use of special apparatus, such as stationary bicycles.
Nutrition
If malnutrition (body weight less than 85 percent of ideal) is present,
oral dietary supplements can result in improved muscle strength, less
fatigability, and lessening of breathlessness.
Respiratory infections
Morbidity, mortality and frequency of acute respiratory illnesses are
higher in patients with chronic bronchitis. Many attempts have been
made to relate these illnesses to infection with viruses, myoplasmas,
and bacteria. However, only the rhinovirus are found just as often
between as during exacerbations.
Infections cannot be totally avoided, and the patient should be made
aware that increasing purulence, viscosity, or volume of secretions
signals the onset of an infection, which should be treated early.
Microscopic examination and culture of sputum are indicated if there
are chills, fever or chest pain.
Familial factors
Familial aggregation of chronic bronchitis has been well documented.
Children of smoking parents may experience more frequent and
severe respiratory illnesses and have a higher prevalence of chronic
respiratory symptoms. In addition, nonsmokers who remain in the
presence of cigarette smokers (passive smokers) have increased
blood levels of carbon monoxide, which indicate that they are
significantly exposed to smoke. Another well-documented form of
indoor air pollution relates to the use of natural gas for cooking.
The role of such pollution, however, remains controversial. Thus a part
of familial aggregation may be related to home air pollution.
33
Chronic bronchitis protocol
6.2.6- Plan of treatment-
1st phase treatment – “Watchful waiting”. The placebo along with the conservative
treatment to be given till such time that there is improvement in the cough and
expectoration. The observation is being done preferably at week’s interval or two
week’s interval as required. In case of no improvement, or aggravation the 2nd phase
treatment should start. The patient should not be prescribed any medicine till
improvement last.
2nd phase Treatment – The indicated medicine along with the general management, to be
followed up at a periodic check-up to assess the progress in the case.
7. PROCEDURES AND METHODS
7.1. Enrollment
The enrollment procedure after presentation to a specific site is as follows:
Four stages for Participant selection
Stage
1:
Preliminary verbal screening by the OPD doctor for presence of inclusion criteria
(FORM A)
Patients will be recruited from those coming to out patients’ department in the
institutes where the study has been assigned. While each site will evolve its own
advocacy procedures for attracting research subjects (advertisements, media,
camps, handouts, etc.), they will all follow the standard recruitment procedure.
The procedure involves a two stage screening prior to initiation of the consent
procedure. The first screening is a verbal screening by the attending physician in
the OPD.
34
Chronic bronchitis protocol
The OPD doctor will verbally screen the patients presenting with symptoms
related to respiratory system between 20-50 years of age by asking the
following questions:
1. How old are you?
2. Have you been suffering from productive cough for more than three
months?
3. Is there copious expectoration?
Details will be kept on the number of patients screened by the OPD doctors. It is
expected that the site investigators will ask the OPD doctor to screen as many
patients as possible. Subjects who are of relevant age and have both, the
productive cough for more than three months and the copious expectoration, will
be sent to the investigating officer for detailed and recorded screening.
Stage
2:
Detailed screening by the investigating officer for presence of inclusion criteria
and absence of all exclusion criteria.
The second screening is a standardized-recorded screening by the project
medical officer/investigating officer ‘FORM’ A
The investigating officer will examine the patient for the presence of inclusion
criteria and exclusion criteria. Those who are potentially eligible for the study
(inclusion criteria present and all exclusion criteria absent) will then be
subjected to a Baseline assessment by the investigating officer to re-confirm
presence of inclusion criteria and absence of all exclusion criteria.
Details will be kept on the number of patients screened by the investigator.
For a site to stay in the study a minimum of 8 subjects must be enrolled in
any month period and follow-up must be more than 95%. In addition, the site
must follow the clinical parts of the protocol stringently. To complete the
study within the stipulated time frame, each site is required to make all efforts
to enroll at least 8 cases per month into the study. This would give a sample
size of about 200. Care must be taken to recruit cases in all twelve months of
a year to represent all seasons.
Stage
3:
Informed written consent of potentially eligible subjects
The purpose of the study will be explained to patients and oral informed
consent to participate obtained. The patients eligible to enter the study will be
fully informed about the study. The content of the explanation provided to the
patients is described in the attached consent form ( Form B1).The site
investigator from all the institutions involved in the study will obtain the freely
given, written consent of the patients to participate in the study. The written
consent form is attached (Form B2). If the patient is not literate, a thumbprint
may be substituted for signature, duly witnessed by somebody in addition to
the person requesting consent.
Stage
Baseline assessment by the Programme officer shall include a detailed Case
35
Chronic bronchitis protocol
4:
record and to re-confirming the presence of inclusion criteria and absence of all
exclusion criteria after carrying out prescribed investigations.
The baseline assessment, using Form C2, will be performed
immediately after presentation to the site within 3 days after presentation to
the site, FORM C1 includes:
i) re-evaluation to ensure that no signs of severe chronic bronchitis
or very severe disease are present and
ii)
a detailed case history for deciding a patient-specific remedy out
of the disease specific medicines indicated in the case.
Data collected at baseline include:
1. Name, age, address, detailed description of location and other
contact information.
2. History of present illness (duration of symptoms, etc.)
3. Medical history to exclude presence of known or suspected
i. emphysema,
cor
pulmonale,
bronchial
asthma,
Bronchiectasis, Active pulmonary tuberculosis (open),
Cystic fibrosis, Bronchopulmonary mycosis, Central
airflow obstruction, acute bronchitis, pneumonia,
pulmonary thrombo-embolism, left ventricular failure,
pulmonary hypertension, chronic respiratory failure,
spontaneous pneumothorax, Bronchogenic carcinoma.
ii. Chronic bronchitis, NOS(J42) and obstructive(J44) as per
ICD 10
iii. Subjects suffering from Persons requiring oxygen therapy
and hospitalization;
iv. Cough due to some other underlying disease.
4. Subjects currently on any other treatment (Homoeopathy or other
systems)
5. Subjects who have discontinued treatment less than two weeks
before,
6. Past history
7. Family history
8. Personal history
9. General and systemic examination
10. Investigations
11. Diagnosis
12. Rubric selection
13. Repertorisation
14. Selection of medicine for the Trial.
15. General management.
The history should include quantification of the degree of cough,
expectoration and exertional dyspnoea during activities of daily living and
36
Chronic bronchitis protocol
typical activities for the patient. The physical examination should incorporate
an assessment of the degree of distress of the patient.
Patients who are no longer eligible for the study at the completion of
baseline evaluation (e.g. because signs of severe chronic bronchitis or very
severe disease have appeared) will be discontinued from the study and
receive usual care as clinically indicated. All the data will be recorded.
The study personnel will explain and demonstrate to the patient how to take
the medicine at home at recruitment and at all subsequent follow-up visits.
Enrolled into study—Yes/No
Enrollment of consenter and registration.
37
Chronic bronchitis protocol
7.2 SELECT THE RUBRICS TO BE TAKEN FOR
REPERTORISATION:
Tick the rubric(s) found in the case
No. 
Chest; inflammation; Bronchial tubes
1
Cough; chronic
2
Expectoration; copious; chronically
3
Cough, winter
4
Expectoration; constant, almost day and
evening
5
Expectoration; copious; paroxysmal
cough, after
6
Expectoration; frequent
7
Respiration; difficult; cough; with
8
Expectoration; mucous
9
Expectoration; mucous; translucent
10
Expectoration; frothy,
11
Expectoration; easy
12
Expectoration; transparent
13
Expectoration, white
14
Expectoration; purulent
15
Expectoration; difficult
16
Expectoration; yellow
17
Expectoration; thick
18
Expectoration; lumpy
19
Expectoration; balls, in shape of
20
Respiration; difficult; exertion, after
21
38
Chronic bronchitis protocol
2
1
1
1
0
0
0
0
0
1
2
0
2
0
02
3
3
3
3
3
3
3
3
3
2
0
2
0
2
03
0
0
1
0
2
1
0
0
0
0
2
1
1
0
04
0
0
0
0
0
0
0
0
0
0
0
0
0
0
05
0
0
0
1
0
0
0
0
0
0
0
0
0
0
06
0
1
0
1
2
0
0
0
0
0
0
0
0
0
07
3
2
0
1
3
3
1
2
2
0
1
1
3
2
08
3
3
3
1
3
3
3
3
2
2
3
3
2
3
09
0
1
0
0
0
3
0
0
0
0
0
0
0
0
10
2
1
0
1
0
3
1
0
0
0
0
1
1
1
11
0
1
1
1
3
0
0
0
1
1
0
0
1
1
12
3
2
0
1
2
2
0
2
0
0
0
1
1
0
13
3
1
1
2
2
2
2
2
2
0
0
1
1
0
14
3
3
1
1
2
2
3
0
1
0
2
1
2
1
15
2
0
2
1
3
2
2
3
0
1
2
1
1
2
16
3
3
0
2
3
2
3
1
2
1
2
1
0
0
17
3
2
2
3
3
2
2
0
3
2
1
1
0
0
18
1
3
2
1
2
2
2
2
1
1
1
1
1
0
19
1
3
0
1
2
2
0
0
1
1
0
1
0
1
20
0
3
0
1
3
2
1
0
0
0
0
0
0
0
21 2
2
0
2
2
3
3
0
2
0
2
0
0
3
Sil.
Phos
Lyc.
Puls.
Calc.
Sulph.
Hep.
Ip.
Bry
Ant-t
Carb-v.
Spong.
Stann.
Total
01
Ars.
7.3 Highlight the row(s) below corresponding to the rubric
no(s). ticked above:
39
Chronic bronchitis protocol
7.4 High scoring medicines:
Medicine:
Value:
7.5 Basis of prescription
Prescription: ____________
Potency: 30.
single
Highlight the disease symptom(s) of
the case
No. State the characteristic
symptoms
Chest; inflammation; Bronchial tubes
1
Cough; chronic
2
Expectoration; copious; chronically
3
Cough, winter
4
Expectoration; constant, almost day and
evening
5
Expectoration; copious; paroxysmal
cough, after
6
Expectoration; frequent
7
Respiration; difficult; cough; with
8
Expectoration; mucous
9
Expectoration; mucous; translucent
10
Expectoration; frothy
11
Expectoration; easy
12
Expectoration; transparent
13
Expectoration, white
14
Expectoration; purulent
15
Expectoration; difficult
16
Expectoration; yellow
17
Expectoration; thick
18
Dose:
40
Chronic bronchitis protocol
Expectoration; lumpy
19
Expectoration; balls, in shape of
20
Respiration; difficult; exertion, after
21
41
Chronic bronchitis protocol
7.6 Assessment
7.6.1 (periodical – two-weekly)
The “zero” will be the time of enrollment. The study personnel will call the patient every two
weeks or earlier, if need be, for the follow-up visit and will examine the patient. The
investigator will review the key variables. Those patients who smoke will be advised to quit
smoking.
All the patients will be taught to recognize the signs of worsening illness according to those
outlined in Baseline assessment form. They will be advised to report to the Institute if any of
the signs develop at any time before the scheduled visit. The following observation will be
made and recorded in case report forms:
1.
Presence or absence of productive cough.
2.
Change in expectoration.
3.
Status of exertional dyspnoea
4.
Presence or absence of added sounds in chest.
5.
Presence or absence of fever.
6.
Any ill contacts; any associated symptoms such as nausea, vomiting, diarrhea,
myalgias, and chills.
7.
Signs of severe chronic bronchitis.
8.
Signs of very severe disease.
9.
Number of doses of medicines taken.
10.
If the patient does not report on a date (fixed) contact shall be made in any way.
The investigator should attempt to establish the severity of exacerbation as well as the
severity of pre-existing disease condition. The more severe, either of these two
components, the more likely, that the patient will require hospital admission.
7.6.2 Outcome assessment
On each follow-up visit an assessment of clinical success or failure shall be made depending
upon an overall response to treatment and the same shall be recorded in a master
assessment chart.
7.6.3 Final Assessment
42
Chronic bronchitis protocol
Assessment of cure will be done either after all the potencies (30, 200 and 1M) of the trial
drug have been used or after a lapse of a term of 6 months from enrollment of the patient
whichever be earlier. Patients who are clinically cured will be discontinued from therapy and
put on periodic observation for a symptom-free period up to two years. Those who are not
improved will be given a changed therapy after a wash-out period of two weeks, following
the same guidelines as for the selection of the first prescription and this case shall be taken
as a new drug trial case in the study.
Degree of improvement1. Marked ( more than 75% improvement in Symptom score from Base line score)
2. Moderate ( 50% to less than 75% improvement in Symptom score from Base line score)
3. Mild ( 25% to less than 50% improvement in Symptom score from Base line score)
4. Not Significant ( less than 25% improvement in Symptom score from Base line score)
II
Worsened ( Increase of Symptom score from Baseline)
III
Static ( No change of Symptom score from Baseline)
7.7.
Treatment schedule (time-line) - -(clinical study on chronic Bronchitis)
Sl.
Time
No.
1 Day 1
Event
Screening
Form to be
filled
FORM A
2
Day 2-5
Baseline assessment and inclusion into
study, consent, case recording and
repertorisation
3
Day 6-8
Homoeopathic therapy initiated
FORMS B1, B2,
C1, C2 ,
Repertorisation
Sheet
Ref. 4.5.2
1 month to
3rd month
5 On
completion
of 3 months
6 On
completion
of 1 year
7 1 year to 2
year
8 On
completion
of 2
9 2 year to 3
year
10 On
completion
of 3 years
Monthly follow-up with photographs
FORM D
Detailed assessment in comparison with
baseline assessment and photographs
FORM E
Repeat assessment, plus photographs
and continuation of therapy, if required
FORM H
Monthly follow-up as required and
continuation of therapy, if required
Repeat assessment, plus photographs
FORMS D, E1,
F1 & G1
FORM H1
Monthly follow-up as required and
continuation of therapy, if required
To prepare the Summary report of each
case studied, so far, under this clinical
study
FORMS D, E2,
F2 & G2
FORM H2
11 After
completion
of 3 years+
Concluding Report
FORM I
4
43
Chronic bronchitis protocol
2 months
8 CRITERIA FOR WITHDRAWAL OF PATIENTS
8.1 when and how to withdraw the subject
It is the responsibility of the site investigator to maintain the patient in the study, provided it
is safe to do so. A patient may be discontinued from the study for any of the following
reasons, that must be documented on the appropriate case report form:
8.1.1. Clinical failure after complete treatment
8.1.1.1 No change in Symptomatology of the subject
8.1.1.2 Aggravation of complaints of the patient
8.1.2
occurrence of a serious adverse event
8.1.2.1 No improvement in symptom score from baseline assessment score
8.1.2.2 Serious Intercurrent illness
8.1.2.3 No adverse events are expected during homoeopathic therapy. But
adverse events may occur as the natural course of the disease.
8.1.3. Patient withdraws consent
8.1.4. Protocol is not followed
8.2 Data collection and Clinical care of withdrawal patients
8.2.1 Such patients will receive medical treatment as directed by their physician.
8.2.2 Procedures at discontinuation of enrollment
The site investigator is responsible for completion of all appropriate case report forms up to
the time that the patient is discontinued from the study.
44
Chronic bronchitis protocol
9 RECORD HANDLING
9.1
confidentiality
all the evaluation forms, reports and other records will be kept in locked file cabinet. The patient
shall be issued an identity card as follows:
Patient identity card for follow up
Patient initials ---research case no--Project.-----------------/yr
date of enrollment----Date of initiation of treatment---------completion of treatment----
date of
12th
month
11th
month
10th
month
9th
month
8th
month
7th
month
6th
month
5th
month
4th
month
3rd
month
2nd
month
remar
ks
date
1st
month
month
Followup visits----.
9.2
RECORD KEEPING
There are 10 study forms that will be completed by all the sites for each subject recruited. There are
2 Consent forms for obtaining the informed written consent of the enrolled case. There are 3
reporting proformas, which are to be sent to HQ, at specified time.
9.3
Dissemination, notifications & reporting –
9.3.1 All data derived from the multicentric study will be the property of the Council.
9.3.2 The principle papers on the primary and secondary out comes emerging from the
multicentric study will be published under joint authorship (task force study). The names
of the scientists who have participated in the proposal development and data analysis
will be listed at the end of the paper in alphabetical order and their specific contribution to
the study will be mentioned.
9.3.2 Sites participating in the multi centric study will then be listed in alphabetical
order. Authorship issue for site investigators will rest with the Director of the Council.
Each site team will be encouraged to produce scientific manuscripts and technical
45
Chronic bronchitis protocol
reports based on their site-specific data. Scientists will be encouraged to present the
findings at scientific conference and meetings with the prior approval of the Director,
CCRH.
9.4 Study management at site:
Each site will be responsible for setting up an information system to keep track of all patients
screened and enrolled and a filling system to keep all study records – case history records,
study protocol and or related documentation and drug distribution records. The site
investigator is responsible for the completeness and accuracy of the study materials
9.5 Case History records:
These include the study case report forms (CRFs) that will contain information
that documents the subject’s ability to participate in the study (including a copy of a
signed consent form) and information from tests and examinations. Whenever
possible copies of supporting documentation of the information contained in the study
case report forms should be kept with each patient’s case history records. All
information in the case history records should be attributable to a specific individual.
Each subject’s case history record will be evaluated to verify the validity and
completeness of the data on the CRF when a study monitor visits the study site.
Each CRF should be complete with follow up sheets and are to be maintained
properly. All corrections to the CRFs must be made without obscuring the original
entry. The revised entry should be inserted and the person making the correction
should sign and date the correction. Only authorized study personnel may complete
or correct case report forms
9.6
Records retention:
Retention of accurate and complete records is essential to establish the validity and
completeness of the study. All records must be retained for 5 years after the data set is
frozen
10. MONITORING AND INSPECTION
10.1
Project Monitoring and reviews :
1. Site visits: Site visits will be made by the monitoring officer at CCRH Hqrs. between
3-6 months after commencement of studies.
2. Presentation of interim data by the site investigator will be made at Hqrs.
3. Data review board will monitor the information with respect to deviations from the
study protocol, in- appropriate enrollment of study subject, missed observations etc.
and will suggest plan to rectify any problems at the site.
10.2 Interim assessment of the study
On the basis of interim report received from the different centers involved in the clinical
study, assessment will be made regarding progress of the clinical study, Interim analysis
46
Chronic bronchitis protocol
will be placed before the data review board for suggestions in improvement or
modifications, if required in the protocol. DRB will also assess for compliance of protocol by
the study site. Non compliance may result into closure of study at particular site.
10.3
Quality control:
Once the project has been cleared by the Scientific Advisory Committee and
Ethical Committee, a
centralized workshop will be organized for research officers (to be involved in specific
study) to ensure
standardization and quality control. An external reviewer will visit all the sites after the
initiation of the study for
quality assurance. A random subset of records from each site will be evaluated for quality
control. Investigators
will be asked to bring all medical records ( and results of laboratory tests etc.) for selected
subjects to data
analysis workshop. Information in the medical records will be compared with the data on
the case report form to
assess completeness and accuracy of reported data.
11
DATA ANALYSIS AND MANAGEMENT:
11.1 Reporting Guidelines
1. All centres will send monthly report as per reporting proforma 1
on case recruitment to headquarters either by fax or e-mail on 1st to
7th of each month.
2. An interim assessment report as per reporting proforma 1I of all
the cases enrolled is to be submitted on completion of 3rd month of
the study of the study.
3. An interim assessment report as per reporting proforma 1II of all
the cases enrolled is to be submitted on completion of 6th month, 9th
month, 1st yr, 2nd yr,3rd yr of the study of the study.
3. Data review board will assess the research data as reported in 6
months assessment form as well as first and second interim report.
4. Final assessment report on completion of the study (after 3 years) is
to be submitted to hqrs as per reporting proforma IV.
11.2
Data analysis plan :
Co-ordinating cell at CCRH hqrs. will finally compile and analyze data
received from all the centres in consultation with Data Review Board.
11.3
Institutional Data Review Board
Institutional Data Review Board (IDRB) shall make Interim review of the data of
the study every six months.
12 TRAINING
A training module will be prepared detailing out various modes of training to be
imparted to the concerned staff at each of the centers of trial.
47
Chronic bronchitis protocol
13 ETHICAL REVIEW
Although homoeopathic medicines, proposed to be used during the study, are
homoeopathic pharmacopoeal preparations (no new drug is proposed to be
tried)Necessary Clearance of the Ethical Committee has been obtained before
under taking the study
14 LIMITATIONS OF STUDY:
1.
Non achievement of sample size at a particular
site/centre –
i.
In case of non achievement of sample size in
the study period, there will be option for extension of the study
for a further limited period after due approval of Scientific
Advisory Committee of the Council.
ii.
If a particular site/centre fails to achieve the
sample size in first 6 months, or not complying to the protocol,
the study will be discontinued and there will be an option for
inclusion of one more centre after due approval of Scientific
Advisory Committee.
2. Since only a group of medicines have been selected for trial
to minimize variables, it may be possible that in some cases,
medicines out of these trial medicines may be indicated as per
symptom similarity. Those cases are to be treated according to
general treatment guidelines of Homoeopathy and are not to be
included in the study.
15. Time line
1.
Draft protocol, submit to EC and IDRB and Constitution
and 1st meeting of the Data Monitoring committee
oct 2005
2.
Pre-trial preparations:
Organise purchase of drugs, equipment, furniture, etc.,
printing of programmes for data entry and management
November 2005
3.
Quality assurance workshops
(For standardized training of appointed investigators at
all centres in outcomes assessment, data collection,
reporting, etc.)
November 2005
4.
Recruitment in main study
november 2005 onwards till
the specified sample size is
achieved, or two years,
48
Chronic bronchitis protocol
whichever be earlier.
6.
Quality assurance site visits:
Quarterly
7.
Interim analysis
April 2006, -07, -08 and
2009
8.
Subsequent meetings of *Data Monitoring Committee
October 2006, 2007, 2008
and 2009
9.
Data compilation and analysis
December 2009
*The Data Monitoring Committee can meet at any time on the call of the Chairperson
16. CASE DEFINITIONS
16.1 Chronic bronchitis
A condition associated with excessive tracheobronchial mucus production sufficient to cause
cough with expectoration for at least 3 months of the year for more than 2 consecutive years.
The patient with chronic bronchitis with obstruction has a long history of cough and sputum
production with a later onset of wheezing, whereas the asthma patient with chronic
obstruction gives a long history of wheezing with later onset of chronic productive cough.
The patient with predominant bronchitis usually has an impressive history of cough and
sputum production for many years with an immodest history of cigarette smoking. Initially the
cough is present only in winter months, and the patient is apt to seek medical attention, if at
all, only during the more severe of the frequent mucopurulent relapses. Over the years the
cough progresses from hibernal to perennial and mucopurulent relapses increase in
frequency, duration and severity. After beginning to experience exertional dyspnoea, the
patient often seeks medical help and will be found to have a severe degree of obstruction.
The patient with predominant bronchitis is often overweight and cyanotic. There is apparently
no apparent distress at rest, the respiratory rate is normal or only slightly increased, and
there is no apparent usage of accessory muscles.
Chest percussion note is normally resonant, and by auscultation one can usually hear coarse
ronchi and wheezes that change in location and intensity after a deep and productive cough.
16.2Simple Chronic bronchitis
Chronic bronchitis characterized by mucoid sputum production
16.3Chronic mucopurulent bronchitis
Chronic bronchitis with persistent or recurrent purulence of sputum in the absence of
localized suppurative diseases such as bronchiectasis.
49
Chronic bronchitis protocol
16.4 Chronic obstructive pulmonary disease (COPD)
Defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD), as a disease
state, characterized by airflow limitation that is not fully reversible. COPD includes
 Emphysema, an anatomically defined condition characterized by destruction and
enlargement of the lung alveoli;
 Chronic bronchitis, a clinically defined condition with chronic cough and phlegm; and
 Small airways disease, a condition in which small bronchioles are narrowed.
50
Chronic bronchitis protocol
 COPD is present only if chronic airflow obstruction occurs; chronic bronchitis without
chronic airflow obstruction is not included within COPD.
16.5. Coarse ronchi and wheezes
Added sounds are abnormal sounds that arise in the lung itself or in the pleura. The added
sounds most commonly arising in the lung are best referred to as wheezes and crackles.
Older terms such as rales to describe coarse crackles, crepitations to describe fine
crackles,and rhonchi to describe wheezes are poorly defined, have led to confusion, and are
best avoided.
Wheezes are musical sounds associated with airway narrowing. Widespread polyphonic
wheezes, particularly heard in expiration, are the commonest and are characteristic of
diffuse airflow obstruction, especially in asthma and chronic obstructive pulmonary disease.
These wheezes are probably related to dynamic compression of the bronchi, which is
accentuated in expiration when airway narrowing is present. A fixed monophonic wheeze
can be generated by localized narrowing of a single bronchus, as may occur in the presence
of a tumour or foreign body. It may be inspiratory or expiratory or both and may change its
intensity in different positions.
Crackles are short, explosive sounds often described as bubbling or clicking noises. When
the large airways are full of sputum, a coarse rattling sound may be heard even without the
stethoscope. However, crackles are not usually produced by moistness in the lungs. It is
more likely that they are produced by sudden changes in gas pressure related to the sudden
opening of previously closed small airways. Crackles at the beginning of inspiration are
common in patients with chronic obstructive pulmonary disease. Localized loud and coarse
crackles may indicate an area of bronchiectasis. Crackles are also heard in pulmonary
oedema. In diffuse interstitial fibrosis, crackles are characteristically fine in character and late
inspiratory in timing. (7)
16.6. Exertional dyspnoea
The development of exertional dyspnoea, often described as increased effort to breathe,
heaviness, air hunger, or gasping, can be insidious. It is best elicited by careful history
focused on typical physical activities and how the patient’s ability to perform them has
changed. Activities involving significant arm work, particularly at or above shoulder level, are
particularly difficult for patients with COPD. Conversely, activities that allow the patient to
brace the arms and use accessory muscles of respiration are better tolerated. Examples of
such activities include pushing a shopping cart, walking on a treadmill, or pushing a
wheelchair. As COPD advances, the principal feature is worsening dyspnoea on exertion
with increasing intrusion on the ability to perform vocational or avocational activities. In the
most advanced stages, patients are breathless doing simple activities of daily living.
16.7 The physical examination
It should incorporate an assessment of the degree of distress of the patient. Specific
attention should be focused on tachycardia, tachypnea, use of accessory muscles, signs of
perioral or peripheral cyanosis, the ability to speak in complete sentences and the patient’s
mental status. The chest examination should establish the presence or absence of focal
findings, degree of air movement, presence or absence of wheezing ,asymmetry in the chest
examination (suggesting large airway obstruction or pneumothorax mimicking an
exacerbation) and the presence or absence of paradoxical motion of abdominal wall.
51
Chronic bronchitis protocol
52
Chronic bronchitis protocol
16.8 Alterations in Ventilatory Function(2)
TLC
RV
VC
FEV1/FVC
MIP
MEP
N to



a
N
N
Pulmonary parenchymal



N to 
N
N
Extraparenchymal - inspiratory

N to 

N
/Nb
N
Extraparenchymal – inspiratory +
expiratory



Variable
/Nb
/Nb
Obstructive
Restrictive
a
Mild obstructive (small airways) disease may have decreased FEF25-75% with normal (N)
FEV1/FVC
b
Reduced if due to respiratory muscle weakness; normal if due to chest wall
stiffness.obstructive (small airways) disease may have decreased FEF25-75% with normal
(N) FEV1/FVC
TLC = Total Lung Capacity
RV = Residual Volume
VC = Vital Capacity
FEV = Forced Expiratory Volume
FVC = Forced Vital Capacity
MIP = Maximum
Inspiratory Pressure
MEP = Maximum Expiratory Pressure
FEF = Forced Expiratory Flow
53
Chronic bronchitis protocol
17
BIBLIOGRAPHY
1. Eugene Braunwald, et al. Harrison’s Principals of Internal Medicine, Volume II, McGrawHill, Medical Publishing Division, 15th Edition 2001; 258:1451-1459..
2. Kasper Dennis L., et al. Harrison’s Principals of Internal Medicine, Volume II, McGrawHill, Medical Publishing Division, 16th Edition 2005; 242:1547-1554.
3. Tierney, Lawrence M., et al. CURRENT Medical Diagnosis & Treatment, Lange Medical
Books/McGraw Hill, Medical Publishing Division, 44th Edition 2005; 9: 235-240.
4. W.H.O., ICD-10, International Statistical Classification of Diseases and Related Health
Problems, Volume 1, World Health Organization, Geneva, Tenth Revision 1992; J40J47:533-537.
5. Haslett, Christopher, et al. Davidson’s Principles and Practice of MEDICINE, Churchill
Livingstone, 19th Edition 2002; 13:508-512, 516.
6. Swash Michael. HUTCHISON’S CLINICAL METHODS, W.B. SAUNDERS, 21st Edition
2002; 5:67.
7. Zendvoort, Roger Van. Complete Repertory, Mac Repertory for Windows, Kent
Homoepathic Associates, USA.
8. Dubey, S.K. Textbook of Materia Medica. Calcutta, Hahnemann Publishing house
9. Hahnemann, Samuel. Organon of Medicine. 6th edition. New Delhi, B. Jain Publishers.
54
Chronic bronchitis protocol
18 ATTACHMENTS
18.1 FORMS (relating to cases registered for clinical study)
Sl.no. FORM
Name
Period
Page
no.
1
FORM A
Detailed
screening
form
At the time of
registration in OPD
66
To be filled for each case
reported in OPD for the
treatment of tropical
eosinophilia
2
Form B1
Patient’s
information
sheet
67
once
3
FormB2
Written
consent form
In case of absence of
exclusion criteria
68
To be filled once in each
case, registered for
assigned clinical study
4
FormC1
Case taking
proforma
To be taken for
eligible subjects
69
To be filled once in each
case, registered for
assigned clinical study
5
FormC2
Baseline
assessment
form
-do-
77
To be filled once in each
case, registered for
assigned clinical study
6
FormD
Follow up
monthly
(assessment)every visit
80
Minimum12(mainly
depends on no. of visits of
patient during the course
of study)
7
FormEG
Assessment –
3rd, 6th, 9th
months
3rd month/6th
82
month/9th month/15th
month/18th month27th
month/21st month/30th
month/33rd month
Maximum 01(mainly
depends on no. of visits of
patient during the course
of study)
8
FormH
Assessment –
on completion
of 1 year
1st year/2nd year/3rd
year
Maximum 01(mainly
depends on no. of visits of
patient during the course
of study)
89
55
Chronic bronchitis protocol
18.2 Study periodical reporting proformae(to be submitted during the course of study)
Sl.no. Study proforma
Name
Number
Page
no.
1
study reporting
proforma I
Monthly
reporting
proforma
12x3
years=36
91
Contains information
related to the month
reported for
2
study reporting
proforma II
Interim
report(after 3
month)
1x3years=3
92
Contains information
related to three
months(April- June)
of the year reported
for
3
study reporting
proforma III
Interim
report(after 6th
month/9th
month/1st yr/2nd
yr/3rd yr
1x3years=3
in each
specified
period
96
Contains information
related to 6/9/12
months(April to
Sept:6 months/April
to December:9
months/April to
March of the
subsequent year:1
year) of the period
reported for
4
study reporting
proforma IV
Consolidated
report
1
100
Contains detailed
information related
to all events within
three years(April
2006 –March2009)
18.3 Others
18.3.1
18.3.2
List of Monitoring committee
o
Dr. Vikram Singh, Co chief coordinator,
o
Dr. Hari Singh,Co chief coordinator,
o
Dr. Jaya Gupta,coordinator,
o
Programme officer at the unit or Incharge of the unit.
List of institutional data review board
56
Chronic bronchitis protocol
FORMS:
FORM A
Detailed Screening Form
Serial number __________
Site Code ______________________
Date _________________
1. Age _____________
2. Sex:
Male/Female
3. Is age >20 and <50 years
Yes
No
4. Reason for OPD attendance:
1. Productive Cough for more than 3
months
Yes
No
2. Copious expectoration
Yes
No
5. Did he/she suffer from similar cough the previous year
Yes
No
6. If ‘yes’ to Sr. Nos. 3, 4 and 5, go through the list below:
Acute Bronchitis
Yes
No
Bronchial asthma
Yes
No
Bronchiectasis
Yes
No
Cystic fibrosis
Yes
No
Pneumonia
Yes
No
Broncho-pulmonary mycosis
Yes
No
Central Airflow Obstruction
Yes
No
Cor pulmonale
Yes
No
Emphysema
Yes
No
Pulmonary Tuberculosis
Yes
No
Need of Oxygen therapy or Hospitalisation
Yes
No
Pulmonary Thrombo-embolism
Yes
No
57
Chronic bronchitis protocol
Pulmonary Hypertension
Yes
No
Bronchogenic Carcinoma
Yes
No
Chronic Respiratory Failure
Yes
No
Left Ventricular Failure
Yes
No
Spontaneous Pneumothorax
Yes
No
Systemic Diseases
Yes
No
Cough due to some other underlying disease
Yes
No
If ‘Yes’ to any one of the above in Q 6, exclude the patient from the study.
IF INCLUDED, PROCEED TO FORM B (BASELINE ASSESSMENT)
Signature
Investigator
Signature
incharge of the institute/unit
58
Chronic bronchitis protocol
FORM B1
Patient Information Sheet
Unique identifier __ / __ __ __ / __ __ __ __
To evolve a group of most efficacious homoeopathic medicines in ‘Simple and Mucopurulent
Chronic bronchitis’
with regard to improvement in the symptom complex of ‘Simple and Mucopurulent Chronic
bronchitis’ :
A multicentric open clinical trial
Purpose of the study
Patients, suffering from perennial chronic cough and copious phlegm which are the symptoms
of chronic bronchitis, need regular and longer treatment. Generally such patients seek
allopathic treatment. Homoeopathic medicines have also been found to be effective in relieving
the distress to a great extent. So far there are no clear cut guidelines for treating chronic
bronchitis using homoeopathic medicines. In this study, we propose to evaluate the efficacy of
homoeopathic medicines in chronic bronchitis.
Study procedures
You have now been screened and it is likely that you are suffering from chronic bronchitis,
which is not severe and can safely be treated at home. We invite you to enroll yourself in this
study. If you are willing to be enrolled in the study, you will be required to undergo certain
investigations at the time of enrolment, free of cost such as Pulmonary Function Test for
measuring the capacity and functioning of your lungs, blood examination, sputum examination
and X-ray chest.You will be examined for the sevierity of the your sufferings.There will be no
adverse affect of any kind by any of these investigations, examinations and treatment. You will
be given homoeopathic treatment for your complaints by which you will be relieved of your
ailments. The benefits to you will be that you will be provided close medical follow up free of
cost by a separate physician and this may also be benefited to any other patient suffering from
similar complaints. You will not know the contents of the medicines prescribed to you during the
trial period but this information will be available to your doctor. Medicine will be supplied in the
form of sugar globules, which will have to be given in doses as your doctor may deem fit for
you. You will be required to be present for follow up every two weeks or earlier if need be for
assessment, after commencing the treatment
Risks from the study
No serious risks are anticipated in this study. We are assuming that you will recover after
homoeopathic treatment given in this trial. However, it is possible that you may not recover
completely. You will be closely followed up and additional treatment administered, if necessary.
The homoeopathic treatment is one of the commonly used treatments for chronic bronchitis. It
has a good safety profile.
Benefits from the study
The results of this study will benefit society by providing information that may justify treatment of
patients suffering from chronic bronchitis that will result in considerable cost savings and may
prevent the patient from developing complications of the disease The benefits to you will be that
you will be provided free consultation and close medical follow up. All medications and
investigations for this study will also be provided free of cost.
Complications
We do not anticipate any serious complications during the study. However, complications may
occasionally arise during the course of the study, due to the disease process. Treatment of
such complications will be carried out by the doctors at no cost to you. No financial
compensation will be provided for such complications.
59
Chronic bronchitis protocol
Compensation
There will be no other financial compensation for participation in the study.
Confidentiality
All information collected in this study will be kept strictly confidential except as may be required
by law. You will not be identified by name if the results of the study are published.
Rights of the participants
Participation in the study is voluntary. Refusal to participate will not influence your care in this
centre in any way. Though we would like all study participants to complete the study, you are
free to withdraw from the study at any time during the course of the study. If at any time during
the course of the study, you have any questions or concerns related to the study, you may
contact the following doctor:
Director , Central Council of Research in Homoeopathy, New Delhi 110058. Phone numbers
25505523, Fax:91-11-25506060 Email- ccrh@del3.vsnl.net.in
Alternatives to participation in the study
You will be seen by one of the doctors in the clinic and provided treatment according to the
regular treatment protocol of the institute.
60
Chronic bronchitis protocol
Form B2
Written Informed Consent Form
Unique identifier __ / __ __ __ / __ __ __ __
Consent
I have had the study explained to me and have read the contents of this form/had the contents
of this form read to me. I have understood the same. I have been given the opportunity to ask
questions and have them answered to my satisfaction. I am willing to be enrolled in the study.
Name of the subject:
Unique identifier __ / __ __ __ / __ __ __ __
(Site/serial/registration numbers)
Signature of patient_________________________________ Date _______________
Signature of the investigator_________________________________ Date _______________
Name of the investigator_________________________________
Signature of witness_________________________________ Date _______________
Name of witness_________________________________
61
Chronic bronchitis protocol
Form C1
Case recording proforma
Registration No…………………
Date….……………..
Name…………………………………..
Name……………………………
Father’s/Husband’s
Age………years Sex - Male/ Female
Religion…………….Nationality……………
Marital status - Single/Married/Widow(er)/Divorcee
Height ……’….”
Weight………KG
Diagnosis…………………………
Occupation………………
Official
Address…………………………………………………..
………………………………………………….………………….
……………………………………………………………………..
Telephone
………………………E.mail………………………..
Residential address:
(A) Temporary:
Address……….…………………………………………………..
………………………………………………….………………….
……………………………………………………………………..
Telephone
………………………E.mail………………………..
(B) Permanent:
Address……….…………………………………………………..
………………………………………………….………………….
……………………………………………………………………..
Telephone
………………………E.mail………………………..
Attending Physician: ……………………………….
___________________________________________________________________
SUMMARY (To be filled after complete case taking)
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Chronic bronchitis protocol
PATIENT’S NARRATION (in
the very expressions used by
him)
PHYSICIAN’S
INTERROGATION [
DETAILS REGARDING
SYMPTIOMS NARRATED]
63
PHYSICIAN’S
OBSERVATION
Chronic bronchitis protocol
PATIENT’S NARRATION (in
the very expressions used by
him)
PHYSICIAN’S
INTERROGATION [
DETAILS REGARDING
SYMPTIOMS NARRATED]
64
PHYSICIAN’S
OBSERVATION
Chronic bronchitis protocol
2.
A.
PRESENTING COMPLAINTS (in chronological order with duration.) Each
symptom should be completed.
location & extension(
includes tissues,
organs,systems.
Extention & spread.
Duration & Frequency)
Sensation (includes
pathology )
Modalities
includes < & >
concomitants
B. Associated complaints(in chronological order with duration.) Each
symptom should be completed.
location & extension
( includes tissues,
organs,systems.
Extention & spread.
Duration & Frequency
Sensation (includes
pathology )
Modalities
includes < & >
65
concomitants
Chronic bronchitis protocol
3. HISTORY OF PRESENT ILLNESS ( includes nature of onset, duration, progress, mode of
treatment, effect of
treatment, and any relation with cause*)
66
Chronic bronchitis protocol
4. LIFE SPACE INVESTIGATIONS (should take form of a biographical account) Record, if
any factor, out of these has relation with present complaints or effect on mind and
disposition of the patient: 4.1 Birth and early development (Mother’s condition during pregnancy; normal or abnormal
birth; feeding difficulties, difficulties in habit training and delay in achieving milestones
(walking, talking and sphincter control, etc.).
4.2
Behaviour during childhood (Play and favourite toys; any periods of separation from
parents and the patient’s reaction to them; temper tantrums; hyperactivity; frequent fights;
violence; model child. Bed-wetting or soiling; eating problems; stammering; recurrent
physical complaints, e.g. abdominal pain).
4.3.
Schooling (Age of starting and finishing school; type of school; academic achievements;
special abilities or disabilities; relationship to peers and teachers; school refusal; school
truancy; ambitions. Obtain information for both primary and secondary schooling).
4.4.
Adolescence & Psychosexual history (Introduction to facts of life; early sexual
experiences; parental attitude towards sex; sexual abuse in childhood. Masturbation and
sexual fantasies; homosexual and heterosexual experiences apart from marriage;
emotional relationship to partners; sexual difficulties; sexual deviation; current sexual
activities. Attitudes to parents, authority figures and peers; reaction to growing up,
puberty and bodily changes; fantasy life; attitude to sexuality including masturbation and
any early homosexual and heterosexual experiences; drug taking; rebelliousness and
delinquency. New interests).
4.5. Occupational history (Age of starting work; jobs held in chronological order and
reasons for change; satisfaction from work; work ability and ambitions; relationship to
work mates, superiors and subordinates. Leisure activities).
____________________________________________________________________________
_________________________
*- precipitating/ exciting/ never well since/ ailments from
67
Chronic bronchitis protocol
4.6. Marital history (Previous engagements and marriages; reasons for marriage; husband’s
or wife’s age, occupation, health and personality; marital relationship – satisfactions,
dissatisfactions, any sexual difficulties; extra-marital relationships and sexual fantasy
life).
4.7. Children (Chronological list of children with ages, first names and health. Miscarriages,
stillbirths or death of a child. Patient’s reactions to these events and attitude to existing
children).
4.8. Present social history (housing, composition of household, financial problems,
emotional atmosphere of home and its effect on patient, diet and daily routine etc.)
4.9. Alcohol and drug history (Details of smoking and drinking habits; any recent change or
adverse effect on physical health or social activity, e.g. occupation, family relationships
and financial situation. Use of other drugs, e.g. heroin, LSD, cocaine, amphetamines,
barbiturates, cannabis, tranquillizers. How are they obtained – prescription, black
market? How are they financed?
4.10 Travel history
4.11Personality before illness (Pre-morbid personality)- include relationships, leisure activities
(hobbies and interests, membership of societies and clubs), predominant mood (anxious,
worrying, cheerful, despondent, optimistic, pessimistic, self depreciating, over confident;
stable or fluctuating; controlled or demonstrative), character (sensitive, reserved, timid, shy,
suspicious, jealous, resentful, quarrelsome, irritable, impulsive, selfish, self centered, self
conscious, lacking in confidence, dependent, strict, fussy, rigid, meticulous, punctual,
excessively tidy), attitudes and standards (moral and religious, attitude towards health and
the body), habits (food, alcohol, tobacco, drugs)
68
Chronic bronchitis protocol
4.12.
Date
5.
S.
no.
Life chart of the patient:
Age
Events
Cause
Expression
Inference
PAST MEDICAL HISTORY (Illnesses, operations and accidents in chronological order;
treatment received – when and by whom. The patient’s reactions to them).
Approx.
Age/Year
**Past Illness (including duration of illness)
Treatment
Adopted Response
**- Includes diagnosed illnesses (if records available) / otherwise presenting complaints &
nature of illness.
69
Chronic bronchitis protocol
6.
FAMILY HISTORY (in case of adoption or fostering, details should be taken of both the
real family, if possible,
and the adoptive or foster family):
Relation
Alive
(age)
Dead
(with
age)
Cause of
death
Father
Mother
Brother
Sister
Son
Daughter
Grandfather
(P)
Grandmother
(P)
Grandfather
(M)
Grandmother
(M)
Uncle (P)
Aunt (P)
Uncle (M)
Aunt (M)
Husband
/Wife
7.
MENSTRUAL HISTORY (if applicable):
Menarche:
Complaints related to Menarche, if any:
70
Illnesses
suffered
/suffering from
Chronic bronchitis protocol
L.M.P.:
Regular/
Character of Flow
COMPLAINTS
irregular
Quantity Consistency Colour Odour Acridity Before During After
Cycle/
& clots
&
menses
Duration
Stains
B. Changes in menstrual functions:
Early years Ist 3-4 years:
Marriage before:
Marriage after:
Pregnancy (ies) after:
Recent:
C. Climacteric:
Age of menopause:
Complaints associated with menopause:
Post menopausal complaints:
D. Abnormal discharges per vagina/ Leucorrhoea:
Character of discharge
Quantity & Colou
consistenc r &
y
Stains
Odou
r
Acridit
y
Relati
on
Modalities including
with
precipitating factors
mense
s
Concomitants
8. OBSTETRIC HISTORY (if applicable): Data of childbirths, including miscarriages and
therapeutic abortions, and complaints related with pregnancies, labor, puerperium and lactation.
7.1 Previous pregnancies including abortion:
71
Chronic bronchitis protocol
G (gravida)
No.
Period
of
pregnan
cy
P (para)
Complaint
s
in
pregnancy
/ treatment
adopted
A (abortion)
Date
&
nature
of
labor*
Nature of
puerperium
S (still birth)
L (Living)
Child
Birt
Aliv
h
e or
wt.
dea
d
Causes
of death
*- Delivery : Home/Hospital, Normal/CS/forceps, episiotomy
7.2 H/o Any gynaecological surgery or intervention
If yes, state the reason:
Yes/No
7.3 Contraceptive methods used/ using:
Reason of change of contraceptive methods
Any complaint from use of contraceptive methods
8. PHYSICAL GENERALS (especially change during illness should be highlighted):
Appetite
Taste
Thirst
Desire / Cravings
Aversion/ Repugnance
Food Aggravation/ Intolerance
Food Amelioration
Stool
1
Physical properties
2
frequency
3
urging
4
satisfaction
5
Modifying factors
6
concomitants
7
any other
72
Lactatio
n
history
Chronic bronchitis protocol
Urine
1
Physical properties
2
Frequency (day/night)
3
urging
4
difficulty
5
control
6
pain
7
Any other
Sweat
1
Physical properties
2
location
3
staining
4
in relation to weather
5
Any other
Discharges
1
Abnormal secretions
2
Excretions
Urethral discharge (In men)
1
Physical properties
2
Modifying factors
3
Concomitants
Sleep (Pattern, position of body during sleep,
sleep related problems, effect of sleep on
health)
Dreams[ Recurrent Persistent,Vivid ]
Tendencies
1
Haemorrhagic
2
Suppurative
3
Catching cold
4
Spasms/Cramps/Sprain
5
Any other
Weakness
Tiredness (Is it loss of energy or boredom, or a
part of general malaise?)
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Chronic bronchitis protocol
Is there unusual fatiguability?
Lassitude
General reaction to:
Factors
Aversion
Desires Intolerance/
Aggravation
Amelioration
Sensitive to
Time
Thermal/ Season
Air/fanning
Clothing
Bathing/Washing
Any food items
Touch/Pressure
Posture
Motion
Noise
Light
Odour
Any other factor(s)
9.-
PSYCHIC FEATURES* with causative or modifying factors, Aberration of mind, morbid
affections of the moral & intellectual.
A. EMOTIONS
(anxiety, anger, fears, greed, company, consolation, conversation,
spoken to, suicidal tendencies, contradiction, trifles, exertion/ work, pleasure/music,
magnetized etc. including
History of emotional upset i.e. anger, bad news, displeasure, repressed /
suppressed), disappointment, fright, grief, joy,
shock,sorrow,tension,vexation,worries,etc.)
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Chronic bronchitis protocol
B. INTELLECT & MEMORY - - {includes Perception (acute/clear/confused/dull,
ecstasy, clairvoyance,
visions, hallucination, illusion etc.), Thinking (active/ sluggish, emotional/ logical,
fancies/ daydreams, difficult, fixed/ changeable, grandiose/ unreal/ practical, reverie /
systematic, delusions/imaginations, confusion, guilt complexes comprehension, etc.,
if any other, specify. loss-sudden, weak, acute/sharp, difficult, absent-minded,
forgets recent event(s) but remembers past events, forgets names/titles/places,
etc.)
C WILL including desire/aversion in general(/ special senses ,strong with a drive
D BEHAVIOUR OF PATIENT - Mild & Placable / Boisterous & Violent/ Firm/ Yielding/
Lively & Communicative/ Reserved & Taciturn/ Anxious/ Apprehensive/ Timorous/
Irritable/ Introvert/ Extrovert, etc.
E. ANY OTHER, SPECIFY
10
PHYSICAL EXAMINATION
10.1 GENERAL PHYSICAL EXAMINATION:
Anaemia ……Jaundice…….. Cyanosis………Oedema (general/ partial)…………
Lymph nodes (cervical, axiliary, inguinal, etc.)……………………….
Blood pressure… …../….. mm of Hg ….Pulse rate………/ min. Temperature……°F
Respiratory rate..…
/ min
_____________________________________________________________________
*- especially change in mind & disposition during disease is to be highlighted.
Also mention:
1. Are the intellectual functions, power of thought, memory or desire or ability for
mental or bodily exercise weakened?
2. Are mental emotions of long continuance, or are they very transient? Whether patient
suffers patiently or is inclined to weep, to be morose, passionate, despairing, greatly
anxious or fearful etc. or whether the mind is remarkably affected in these respects by
the disease?
10.2
REGIONAL EXAMINATION*:
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Chronic bronchitis protocol
Body Built
(Obese/ lean/ stocky)
Stature
large/ small
Weight
Kg.
(Increasing/decreasing/stationary)
Gait
Posture
Deformities
Complexion
(Fair/ wheatish/ dark/ florid/ pale)
Clean/dirty
Look
Premature old/ Childish/ young/ Senile
Facial configuration &
expression
Scalp / Head
Hair
(colour & condition)
Eyes
Pupil
Vision
Ears
Ear wax
Dry/ fluid, fetid/ odorless
Hearing
Chin
Jaw
Nose
Mouth
Taste
Lips
Tongue
Gums
Breath (odour)
Teeth
Speech & voice
Pulse
Hand
Palms
Fingers (Clubbing)
Nails
Toes
Thyroid
Perspiration
Location
Physical properties
Acrid, Bloody, Burning, Clammy, Cold,
Warm, Diminished, Excessive, Odors, Oily,
Staining, Sticky, Suppressed, absent
SKIN
Coldness
General
Partial (location)
Heat, Warmth
General
Partial (location)
Any growths (Tumuors,
Exanthemata, Warts, Corns,
Cysts etc)
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Chronic bronchitis protocol
Discoloration
______________________________________________________________________
___
*- Give tick (  ) mark wherever applicable
10.3.
SYSTEMIC EXAMINATION* [DETAILS MAY BE TAKEN
ACCORDING TO
RESEARCH
PROTOCOL](Firstly and thoroughly the system under suspicion- Next other systems in
turn, considering the important points only). Basically each system is examined by
i. Inspection ii. Palpation iii. Percussion iv. Auscultation
v.
Special and
Instrumental
examination as and when necessary.
Detail of system affected
Respiratory system-
Cardiovascular system-
Nervous system-
Gastro-intestinal
system-
Genito urinary system-
Locomotor system
Joints and bones-
11. LABORATORY INVESTIGATIONS (whichever applicable to the research
project)
(Including previous investigations got done by the patient, if any. Positive findings
may be recorded in the relevant annexure of assigned problem) (Attach separate
sheet)
12.
DIAGNOSIS :
77
Chronic bronchitis protocol
13.
ANALYSIS AND EVALUATION OF SYMPTOMS:-
Causation
Mental
generals
Physical
generals
(including side
affinity, if any)
Uncommon
symptoms
Particulars
Common
symptoms
(Characteristic, Key
Note, Peculiar
sensations,
Concomitants,
Modalities etc.)
Score
14.
BASELINE SYMPTOM SCORE
(Attach Baseline (document)
15. MIASMATIC ANALYSIS:
Symptoms
Psora
Sycosis
Syphilis
Tubercular
Conclusion-Dominant miasm:
16.
TOTALITY OF SYMPTOMS:[PQRS* in respect of Mental/ Physical Generals & Particulars; Causation; Past history;
Family history & Pathological changes]
17. SELECTION OF MEDICINE: (attach Repertorial sheet, wherever applicable)
17.1. - Repertorization-
78
Chronic bronchitis protocol
Repertory used:
Method of RepertorizationChapter
Symptoms Selected
Rubrics
________________________________________________________________________________
*- Peculiar, Queer, Rare symptoms
17.2 Repertorial analysis:
18. FIRST PRESCRIPTION:
18.1.
Justification of the prescription
18.2.
Prescription
Date …………..
Name of medicine and potency ………………………..….
Dosage ………
Number of days……………….
18.3.
General Supportive Care:[According to protocol ]
79
Chronic bronchitis protocol
NOTE: - 1. Case taking should be in legible writing
2. No column should be left blank
3. NP- nothing particular
4. NK – not known
signature
signature
investigator
Incharge of the institute/unit
80
Chronic bronchitis protocol
Form C2
Baseline Assessment
Serial number __________
Site Code ______________________
Date _________________
Name of Patient ______________________________________ Sex: Male/Female
_______________
Age
Address
____________________________________________________________________________
________
_________________________________________ Tel ___________________ e-mail
______________________
1. HAS THE WRITTEN INFORMED CONSENT OF THE PATIENT BEEN TAKEN: Yes /
No
If ‘Yes’ then proceed further.
2. HISTORY OF CURRENT ILLNESS (Complete or circle correct response):

Duration of productive cough :
months).

_______ (valid more than 3
Seasonal: summer/winter/rainy/change.
1. Symptom score at entry level
Symptom/Score
0
1

1.
Chronic
Absen
Cough
t
Severity
Mild
(irritating)
Paroxysms
nil
1 hr to 6 hrs
[duration]
2.
Expectorati
Absen
on
t
Difficulty in raising
Easy
Quantity
Scanty
Thin
2
4.
Crackles
Absen
t
Absen
t
Absen
3
4
12 hrs to 18
hrs
Severe
(spasmodic)
18 hrs to 24
hrs
Present
Moderate
(distressing)
6 hrs to 12
hrs
present
Difficult
Copious
Thick
Mucoid
Transparent/
Translucent
3.
Difficult
respiration
_______ days
Frothy
White
Yellow
Lumpy/
in shape of
balls
Purulent
Greenish
Mild exertion
With cough
Present
Heavy
exertion
Present
81
Chronic bronchitis protocol
t
Total
Total of Entry level score: ______________ [10-40]
MILD: 10 to 15
MODERATE: 16 to 31
SEVERE:32 -40
HISTORY OF ATTACKS IN THE PREVIOUS YEARS
2. Duration of illness in years:
___________
3. Duration of attacks of productive cough :
_______ (valid more than 3 months)
4. Seasonal: summer/winter/rainy/change.
_______ days
HISTORY OF EXPOSURE TO POLLUTANTS
5. Smoking [ Active/Passive; Duration: ___________; No. of cigarettes per day
___________ ]
6. Environment (Air pollution)/Occupation
7. Respiratory infections
8. Familial factors
82
Chronic bronchitis protocol
ROUTINE PHYSICAL EXAMINATION (7 )
General
• General appearance (does
the patient look healthy,
unwell or ill, well cared for
or neglected?)
• Intelligence and
educational level
• Mental state
• Expression and emotional
state
• Build and posture
• Skin colour, cyanosis,
anaemia, jaundice, pigmen
tation
• Temperature, pulse,
respiration rate
Eyes
• Oedema of the lids
• Gonjunctivae: anaemia,
jaundice or inflammation
• Pupils: size, equality,
regularity, reaction to light,
accommodation
Mouth
Pharynx
• State of tonsils.
Neck
• Lymphatic glands
Upper limbs
• Fingernails: clubbing or
koilonychia
• Pulse: rate, rhythm,
volume and character
83
Chronic bronchitis protocol
• Axillae: lymph glands
• Blood pressure
Chest
• Respiration: rate, depth
and character
• Position of trachea by
palpation
• Palpate respiratory
movements
• Estimate tactile vocal
fremitus
• Percuss the lungs
• Auscultate the heart
sounds
• Auscultate the breath
sounds
Posteriorly (patient
sitting)
• Inspect and palpate
respiratory movement
• Estimate tactile vocal
fremitus
• Percuss the lung
resonance
• Auscultate the breath
sounds
• Estimate vocal resonance
Abdomen
• Hernial orifices
• Palpation: tenderness,
rigidity, hyperaesthesia,
splashing, masses, liver,
gallbladder, spleen,
kidneys, bladder
• Percussion: masses, liver,
spleen, bladder
84
Chronic bronchitis protocol
• Auscultation: bowel
sounds, murmurs
Lower limbs
• General examination of
legs and feet
• Oedema of feet and
ankles
• Varicose veins
• Joints: movement, pain
and swelling
Examination of excreta
• Test urine for specific
gravity, sugar, protein and
blood.
INVESTIGATIONS
Spirometry:
Normal values
• FEV1
• FEV1/FVC
• TLC
• Residual Volume
• Vital Capacity
X-ray chest:
Pathological:
• Hb%
• TLC
• DLC
• ESR
• Sputum for AFB (3
consecutive days)
• ELISA for Mycobacterium
Tuberculosis
85
Chronic bronchitis protocol
Enrolled into study: Yes / No.
signature
Signature
Signature
consultant
Investigator
86
incharge of the institute/unit
Chronic bronchitis protocol
FORM D
Follow up [at every visit]
unique identifier- Site code/screening no./baseline assessment no./research case
no./OPD regd no.
Date _________________
Name of Patient ______________________________________ Sex: Male/Female
_______________
Age
Address
____________________________________________________________________________
________
_________________________________________ Tel ___________________ e-mail
______________________
HISTORY OF CURRENT ILLNESS (Complete or circle correct response):
1. Symptom score at entry level
Symptom/Score
0
1

Chronic Cough
Absen
t
Severity
Mild
(irritating)
Paroxysms
nil
1 hr to 6 hrs
[duration]
Expectoration
Absen
1 hr to 6 hrs
t
Difficulty in raising
Easy
Quantity
Scanty
Thin
2
Crackles
Absen
t
Absen
t
Absen
t
4
Present
Moderate
(distressing)
6 hrs to 12
hrs
6 hrs to 12
hrs
Mucoid
Transparent/
Translucent
Difficult respiration
3
Frothy
White
12 hrs to 18
hrs
12 hrs to 18
hrs
Difficult
Copious
Thick
Severe
(spasmodic)
18 hrs to 24
hrs
18 hrs to 24
hrs
Yellow
Lumpy/
in shape of
balls
Purulent
Greenish
Mild exertion
With cough
Present
Heavy
exertion
Present
Total
Total of Entry level score: ______________ [10-40]
MILD: 10 to 15
MODERATE: 16 to 31
SEVERE:32 -40
87
Chronic bronchitis protocol
INVESTIGATIONS
Spirometry:
Normal values
• FEV1
• FEV1/FVC
• TLC
• Residual Volume
• Vital Capacity
X-ray chest:
Pathological:
• Hb%
• TLC
• DLC
• ESR
• Sputum for AFB (3
consecutive days)
• ELISA for Mycobacterium
Tuberculosis
88
Chronic bronchitis protocol
2. ROUTINE PHYSICAL EXAMINATION (7 )
General
• Temperature, pulse,
respiration rate
Pharynx
• Lymphatic glands
• Pulse: rate, rhythm,
volume and character
• Axillae: lymph glands
• Blood pressure
Chest
• Respiration: rate, depth
and character
• Position of trachea by
palpation
• Palpate respiratory
movements
• Estimate tactile vocal
fremitus
• Percuss the lungs
• Auscultate the heart
sounds
• Auscultate the breath
sounds
Posteriorly (patient
sitting)
• Inspect and palpate
respiratory movement
• Estimate tactile vocal
fremitus
• Percuss the lung
resonance
• Auscultate the breath
sounds
89
Chronic bronchitis protocol
• Estimate vocal resonance
MEDICAMENTS, Treatment
Compliance to Homoeopathic treatment
a)
Medicines prescribed
b)
Continuation of treatment
c)
Name of the medicine if changed (Reasons for change)
d)
Number of doses taken
Compliance to Instructions
1. Whether medicine taken regularly
2. How many times not taken on scheduled time
3. Any other medicines taken
4. Follow-up of general management (REF 6.2.6)
Other symptoms of the patient as per initial case record:
a) --------b) --------c) --------- Remarks, if any
signature
Signature
Signature
consultant
Investigator
90
incharge of the institute/unit
Chronic bronchitis protocol
FORM E,F,G
Assessment [at 3 months/ 6 months/at 9 months/15th/18th /21st/27th month /30th month/33rd
month]
unique identifier- Site code/screening no./baseline assessment no./research case
no./OPD regd no.
Date _________________
Name of Patient ______________________________________ Sex: Male/Female
_______________
Age
Address
____________________________________________________________________________
________
_________________________________________ Tel ___________________ e-mail
______________________
3. Symptom score at entry level
Symptom/Score
0
1

Chronic Cough
Absen
t
Severity
Mild
(irritating)
Paroxysms
nil
1 hr to 6 hrs
[duration]
Expectoration
Absen
1 hr to 6 hrs
t
Difficulty in raising
Easy
Quantity
Scanty
Thin
2
Crackles
Absen
t
Absen
t
Absen
t
4
Present
Moderate
(distressing)
6 hrs to 12
hrs
6 hrs to 12
hrs
Mucoid
Transparent/
Translucent
Difficult respiration
3
Frothy
White
12 hrs to 18
hrs
12 hrs to 18
hrs
Difficult
Copious
Thick
Severe
(spasmodic)
18 hrs to 24
hrs
18 hrs to 24
hrs
Yellow
Lumpy/
in shape of
balls
Purulent
Greenish
Mild exertion
With cough
Present
Heavy
exertion
Present
Total
Total of Entry level score: ______________ [10-40]
MILD: 10 to 15
MODERATE: 16 to 31
SEVERE:32 -40
91
Chronic bronchitis protocol
INVESTIGATIONS
Spirometry:
Normal values
• FEV1
• FEV1/FVC
• TLC
• Residual Volume
• Vital Capacity
X-ray chest:
Pathological:
• Hb%
• TLC
• DLC
• ESR
• Sputum for AFB (3
consecutive days)
• ELISA for Mycobacterium
Tuberculosis
MEDICAMENTS, Treatment
Compliance to Homoeopathic treatment
a)
Medicines prescribed
b)
Continuation of treatment
c)
Name of the medicine if changed (Reasons for change)
d)
Number of doses taken
Compliance to Instructions
5. Whether medicine taken regularly
6. How many times not taken on scheduled time
7. Any other medicines taken
8. Follow-up of general management (REF 6.2.6)
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Chronic bronchitis protocol
Other symptoms of the patient as per initial case record:
a) --------b) --------c) --------- Remarks, if any
Symptom score at Entry level [n0]: _________________
Symptom score after 3 month follow-up [n3]:: __________
Difference in symptom score: ____________ (value in plus or minus)
Overall response to treatment: Better (plus) / No response (zero) / Worse (minus).
Improvement rate: [(n0 - n3) /0.4] %
: ____________
(value in plus or minus).
signature
Signature
Signature
consultant
Investigator
93
incharge of the institute/unit
Chronic bronchitis protocol
FORM H
Assessment [at 12 months /2yrs/3yrs]
unique identifier- Site code/screening no./baseline assessment no./research case
no./OPD regd no.
Date _________________
Name of Patient ______________________________________ Sex: Male/Female
_______________
Age
Address
____________________________________________________________________________
________
_________________________________________ Tel ___________________ e-mail
______________________
4. Symptom score at entry level
Symptom/Score
0
1

Chronic Cough
Absen
t
Severity
Mild
(irritating)
Paroxysms
nil
1 hr to 6 hrs
[duration]
Expectoration
Absen
1 hr to 6 hrs
t
Difficulty in raising
Easy
Quantity
Scanty
Thin
2
Crackles
Absen
t
Absen
t
Absen
t
4
Present
Moderate
(distressing)
6 hrs to 12
hrs
6 hrs to 12
hrs
Mucoid
Transparent/
Translucent
Difficult respiration
3
Frothy
White
12 hrs to 18
hrs
12 hrs to 18
hrs
Difficult
Copious
Thick
Severe
(spasmodic)
18 hrs to 24
hrs
18 hrs to 24
hrs
Yellow
Lumpy/
in shape of
balls
Purulent
Greenish
Mild exertion
With cough
Present
Heavy
exertion
Present
Total
Total of Entry level score: ______________ [10-40]
MILD: 10 to 15
MODERATE: 16 to 31
SEVERE:32 -40
94
Chronic bronchitis protocol
INVESTIGATIONS
Spirometry:
Normal values
• FEV1
• FEV1/FVC
• TLC
• Residual Volume
• Vital Capacity
X-ray chest:
Pathological:
• Hb%
• TLC
• DLC
• ESR
• Sputum for AFB (3
consecutive days)
• ELISA for Mycobacterium
Tuberculosis
MEDICAMENTS, Treatment
Compliance to Homoeopathic treatment
a)
Medicines prescribed
b)
Continuation of treatment
c)
Name of the medicine if changed (Reasons for change)
d)
Number of doses taken
Compliance to Instructions
9. Whether medicine taken regularly
10. How many times not taken on scheduled time
11. Any other medicines taken
12. Follow-up of general management (REF 6.2.6)
95
Chronic bronchitis protocol
Other symptoms of the patient as per initial case record:
a) --------b) --------c) --------- Remarks, if any
Symptom score at Entry level [n0]: _________________
Symptom score after 12 month follow-up [n12]:: __________
Difference in symptom score: ____________ (value in plus or minus)
Overall response to treatment: Better (plus) / No response (zero) / Worse (minus).
Improvement rate: [(n0 – n12) /0.4] %
: ____________
(value in plus or minus).
signature
Signature
Signature
consultant
Investigator
96
incharge of the institute/unit
Chronic bronchitis protocol
STUDY REPORTING PROFORMA I
1)
MONTHLY REPORTING PROFORMA
.
Name of the Institute/Unit
2)
Title of Study
3)
Name of Reporting Officer
4)
No. of cases Attended O.P.D.
T
M
F
New
Old
Total
5)
No. of cases Registered so far since Inception
6)
No. of cases screened
7)
No. of cases given informed consent
8)
No. of cases Investigated for Diagnosis
X-ray
PFT
9)
No. of cases with confirmed diagnosis.
10) No. of cases found suitable for inclusion into the
study.
11) No. of old cases followed up
a) No. of cases excluded.
b) No. of cases dropped out.
c)
No. of cases discontinued from study
d)
No. of cases referred
12) Registration no. of case records enclosed
13)
1.
No. of Visits Consultant
2. No. of patient seen
New
Old
T
M
F
Note- Enclose one copy of one case record of chronic bronchitis registered during the reporting
month & follow-up sheet for the case record submitted in the previous monthly report..
97
Chronic bronchitis protocol
Follow-up action report in respect of Cases not cleared in
i) Screening, ii) Base line assessment and the cases withdrawn from the study
Project
Total no. of cases loss of follow up
S.No.
Ref.No.
Name
Age
Sex
Screened
Base
line
Signature
Investigator
Withdrawn
Reason
Action
taken
Signature
Incharge of the
Instt./Unit
98
Rx
Institute
Chronic bronchitis protocol
Study Reporting Proforma II
INTERIM REPORT
( After 3 months)
1
INTRODUCTION
1.1.
Title of the Study:
1.2.
Name of the Institute/Unit:
1.3.
Period of Interim Report:
1.4.
Primary Objective of the Study:
To ascertain therapeutic efficacy of Homoeopathic Medicine(s) in the management
of Chronic Bronchitis.
1.5.
Secondary Objective of the Study:
To ascertain the role of Homoeopathic medicine and to establish verified
characteristic symptoms of medicine used.
To assess the role of homoeopathic medicines in reversing the pathological
changes due to Chronic Bronchitis.
Determine the most useful strategy for management of the differing intensity.
To check the progression to complications.
To prevent the relapse.
1.6
No. of cases Attended O.P.D.
T
M
F
T
M
F
New
Old
Total
1.7
No. of cases Registered so far since Inception
1.8.
No. of Cases Studied:
1.9.
Staff Engaged in the Project:
Name
Qualification
Designation
i)
ii)
iii)
iv)
v)
1.10.
Number of subject presenting with following symptoms and signs:
New
Old
Symptoms/ signs
99
Chronic bronchitis protocol
T
1.11
M
F
T
M
F
Examination
findings:
i)
ii)
iii)
iv)
v)
1.10- pathological findings –
New
1.
2.
3.
4.
5.
Old
X-ray findingPFTany other finding-
2- material–
2.1- total no. of research cases
T
M
F
1.
Screened
2.
included in study
3.
Excluded
4.
dropped out
5.
loss to follow-up
6.
Withdrawn
2.2- age distribution
New
100
Old
Chronic bronchitis protocol
1.
40-50 yrs
2.
50-60 yrs
3.
60-70 yrs
4.
5.
2.3- duration of complaintsNew
Old
New
Old
1.
range- Minimum ______________
2.
Maximum ___________________
3.
3 months- to less than 6 months
4.
6 months to less than 1 yr
5.
1 yr to less than 5 yr
6.
6 yr to less than 10 yr
7
11 yr to less than 15 yr
8
16 yr to less than 20 yr
9
20 yrs and above
2.4- predisposition1.
2.
smoking
exposure to allergens
2.5- clinical types of chronic bronchitis
1.
simple
2.
mucopurulent
2.6- baseline information & post treatment symptom score
baseline
1.
10-15
2.
16-31
3
32-40
2.7- reduction in baseline symptom score after treatment
T
1.
more than 1 and less than 5
2.
b/w 5 & 6 less than 8
3
more than 8 & less than 10
4
more than 10 & less than 15
2.8- improvement in pathological /examination findingsBefore
Treatment
1.
decrease in crackles
2.
change in X-ray finding
a
normal
b
abnormal
3
changes in PFT
post treatment
M
After Treatment
3- basis of prescription
New
1.
2.
3
4
mental symptoms
physical characteristics
repertorial totality
101
Old
Chronic bronchitis protocol
3.1- duration of treatment
New
Old
New
Old
1.
Minimum
2.
Maximum
3
0-3 months
4
3-6months
5
6-9 months
6
9months to 1 yr
7
more than 1 year
3.2- improvement indices—
I degree of improvement1.
2.
3
Marked
Moderate
Mild
II
III
IV
Worsened
Static
Referred for other treatment-
3.3.1.
Sl.
No.
Name of Drug
with Potency &
Dosage
Indication
No. of
cases
Medicine
Prescribed
NO. OF CASES
Improvement
Mild
Moderate
3.3.2.
Name of Drug
Clinical symptoms
improved
No. of cases
4. Relapse
Relapse with intensity Before and After Treatment
Intensity Before Treatment
No of Cases
Intensity After Treatment
No of
No of Cases
Cases Mild Moderate
No of Cases
Severe
Mild
Moderate
Severe
5.
Progression to complications.
Complications
Name of Medicine(s) with No. of cases
potency
102
Marked
Chronic bronchitis protocol
Number of cases referred for other therapy/ clinical failure
Baseline
Score
Duration
of Score At Time No.of Medicines Used
Treatment
Of Referral
Age Of Case
Number of adverse events
Name of Duration
of Management
adverse
Treatment
Done
event
Name of Medicines Response
Used if homoeopathic Treatment
Management
The most useful strategy for management of the differing intensity
6.
6.1.
Problems faced by Inst/Unit during implementation of study.
6.2.
Suggestions for rectifying these problems
6..3.
Any Special Achievement
Signature
Signature
Investigator
incharge of the institute/unit
103
to
Chronic bronchitis protocol
REPORTING PROFORMA III
INTERIM REPORT
( ( 6 months / 9months / 12 months/2yrs/3yrs ))
(To be submitted to Hqrs.)
1
INTRODUCTION
1.1.
Title of the Study:
1.2.
Name of the Institute/Unit:
1.3.
Period of Interim Report:
1.4.
Primary Objective of the Study:
To ascertain therapeutic efficacy of Homoeopathic Medicine(s) in the management
of Chronic Bronchitis.
1.5.
Secondary Objective of the Study:
To ascertain the role of Homoeopathic medicine and to establish verified
characteristic symptoms of medicine used.
To assess the role of homoeopathic medicines in reversing the pathological
changes due to Chronic Bronchitis.
Determine the most useful strategy for management of the differing intensity.
To check the progression to complications.
To prevent the relapse.
1.6
No. of cases Attended O.P.D.
T
M
F
T
M
F
New
Old
Total
1.7
No. of cases Registered so far since Inception
1.8.
No. of Cases Studied:
1.9.
Staff Engaged in the Project:
Name
Qualification
i)
ii)
iii)
iv)
104
Designation
Chronic bronchitis protocol
v)
1.10.
1.11
Number of subject presenting with following symptoms and signs:
New
Old
Symptoms/ signs
T
M
F
T
M
F
Examination
findings:
i)
ii)
iii)
iv)
v)
1.10- pathological findings –
New
1.
2.
3.
4.
5.
Old
X-ray findingPFTany other finding-
2- material–
2.1- total no. of research cases
T
1.
2.
Screened
included in study
105
M
F
Chronic bronchitis protocol
3.
Excluded
4.
dropped out
5.
loss to follow-up
6.
Withdrawn
2.2- age distribution
New
Old
New
Old
New
Old
1.
40-50 yrs
2.
50-60 yrs
3.
60-70 yrs
4.
5.
2.3- duration of complaints1.
range- Minimum ______________
2.
Maximum ___________________
3.
3 months- to less than 6 months
4.
6 months to less than 1 yr
5.
1 yr to less than 5 yr
6.
5 yr to less than 10 yr
7
10 yr to less than 15 yr
8
15 yr to less than 20 yr
9
20 yrs and above
2.4- predisposition1.
2.
smoking
exposure to allergens
2.5- clinical types of chronic bronchitis
1.
simple
2.
mucopurulent
2.6- baseline information & post treatment symptom score
baseline
1.
10-15
2.
16-31
3
32-40
2.7- reduction in baseline symptom score after treatment
T
1.
more than 1 and less than 5
2.
b/w 5 & 6 less than 8
3
more than 8 & less than 10
4
more than 10 & less than 15
2.8- improvement in pathological /examination findingsBefore
Treatment
1.
decrease in crackles
2.
change in X-ray finding
a
normal
b
abnormal
3
changes in PFT
3- basis of prescription
106
post treatment
M
After Treatment
Chronic bronchitis protocol
New
1.
2.
3
4
Old
mental symptoms
physical characteristics
repertorial totality
3.1- duration of treatment
New
Old
New
Old
1.
Minimum
2.
Maximum
3
0-3 months
4
3-6months
5
6-9 months
6
9months to 1 yr
7
more than 1 year
3.2- improvement indices—
I degree of improvement1.
2.
3
Marked
Moderate
Mild
II
III
IV
Worsened
Static
Referred for other treatment-
3.3.1.
Sl.
No.
Name of Drug
with Potency &
Dosage
Indication
No. of
cases
Medicine
Prescribed
NO. OF CASES
Improvement
Mild
Moderate
3.3.2.
Name of Drug
Clinical symptoms
improved
No. of cases
4. Relapse
Relapse with intensity Before and After Treatment
Intensity Before Treatment
No of Cases
Intensity After Treatment
No of
No of Cases
Cases Mild Moderate
Mild
Moderate
Severe
107
No of Cases
Severe
Marked
Chronic bronchitis protocol
5.
Progression to complications.
Complications
Name of Medicine(s) with No. of cases
potency
Number of cases referred for other therapy/ clinical failure
Baseline
Score
Duration
of Score At Time No.of Medicines Used
Treatment
Of Referral
Age Of Case
Number of adverse events
Name of Duration
of Management
adverse
Treatment
Done
event
Name of Medicines Response
Used if homoeopathic Treatment
Management
The most useful strategy for management of the differing intensity
6.
6.1.
Problems faced by Inst/Unit during implementation of study.
6.2.
Suggestions for rectifying these problems
6..3.
Any Special Achievement
Signature
Signature
Investigator
incharge of the institute/unit
108
to
Chronic bronchitis protocol
REPORTING PROFORMA IV
( ( consolidated report))
(To be submitted to Hqrs.)
1
INTRODUCTION
1.1.
Title of the Study:
1.2.
Name of the Institute/Unit:
1.3.
Period of Interim Report:
1.4.
Primary Objective of the Study:
To ascertain therapeutic efficacy of Homoeopathic Medicine(s) in the management
of Chronic Bronchitis.
1.5.
Secondary Objective of the Study:
To ascertain the role of Homoeopathic medicine and to establish verified
characteristic symptoms of medicine used.
To assess the role of homoeopathic medicines in reversing the pathological
changes due to Chronic Bronchitis.
Determine the most useful strategy for management of the differing intensity.
To check the progression to complications.
To prevent the relapse.
1.6
No. of cases Attended O.P.D.
T
M
F
T
M
F
New
Followed up
Total
1.7
No. of cases Registered so far since Inception
1.8.
No. of Cases Studied:
1.9.
Staff Engaged in the Project:
Name
Qualification
i)
ii)
iii)
iv)
v)
109
Designation
Chronic bronchitis protocol
1.10.
1.11
Number of subject presenting with following symptoms and signs:
New
Old
Symptoms/ signs
T
M
F
T
M
F
Examination
findings:
i)
ii)
iii)
iv)
v)
1.10- pathological findings –
New
1.
2.
3.
4.
5.
Old
X-ray findingPFTany other finding-
2- material–
2.1- total no. of research cases
T
1.
2.
3.
4.
5.
6.
Screened
included in study
Excluded
dropped out
loss to follow-up
Withdrawn
110
M
F
Chronic bronchitis protocol
2.2- age distribution
New
Old
New
Old
New
Old
1.
40-50 yrs
2.
50-60 yrs
3.
60-70 yrs
4.
5.
2.3- duration of complaints1.
range- Minimum ______________
2.
Maximum ___________________
3.
3 months- to less than 6 months
4.
6 months to less than 1 yr
5.
1 yr to less than 5 yr
6.
5 yr to less than 10 yr
7
10 yr to less than 15 yr
8
15 yr to less than 20 yr
9
20 yrs and above
2.4- predisposition1.
2.
smoking
exposure to allergens
2.5- clinical types of chronic bronchitis
1.
simple
2.
mucopurulent
2.6- baseline information & post treatment symptom score
baseline
1.
10-15
2.
16-31
3
32-40
2.7- reduction in baseline symptom score after treatment
T
1.
more than 1 and less than 5
2.
b/w 5 & 6 less than 8
3
more than 8 & less than 10
4
more than 10 & less than 15
2.8- improvement in pathological /examination findingsBefore
Treatment
1.
decrease in crackles
2.
change in X-ray finding
a
normal
b
abnormal
3
changes in PFT
post treatment
M
After Treatment
3- basis of prescription
New
1.
2.
3
mental symptoms
physical characteristics
repertorial totality
111
Old
Chronic bronchitis protocol
4
3.1- duration of treatment
New
Old
New
Old
1.
Minimum
2.
Maximum
3
0-3 months
4
3-6months
5
6-9 months
6
9months to 1 yr
7
more than 1 year
3.2- improvement indices—
I degree of improvement1.
2.
3
Marked
Moderate
Mild
II
III
IV
Worsened
Static
Referred for other treatment-
3.3.1.
Sl.
No.
Name of Drug
with Potency &
Dosage
Indication
No. of
cases
Medicine
Prescribed
NO. OF CASES
Improvement
Mild
Moderate
3.3.2.
Name of Drug
Clinical symptoms
improved
No. of cases
4. Relapse
Relapse with intensity Before and After Treatment
Intensity Before Treatment
No of Cases
Intensity After Treatment
No of
No of Cases
Cases Mild Moderate
No of Cases
Severe
Mild
Moderate
Severe
5.
Progression to complications.
Complications
Name of Medicine(s) with No. of cases
112
Marked
Chronic bronchitis protocol
potency
Number of cases referred for other therapy/ clinical failure
Baseline
Score
Duration
of Score At Time No.of Medicines Used
Treatment
Of Referral
Age Of Case
Number of adverse events
Name of Duration
of Management
adverse
Treatment
Done
event
Name of Medicines Response
Used if homoeopathic Treatment
Management
The most useful strategy for management of the differing intensity
6.
6.1.
Problems faced by Inst/Unit during implementation of study.
6.2.
Suggestions for rectifying these problems
6..3.
Any Special Achievement
Signature
Signature
Investigator
incharge of the institute/unit
113
to
Chronic bronchitis protocol
114