APPROVED BY
Head Physician of the Municipal Medical and
Preventive Treatment Institution of the Clinical
Maternity Hospital №4 of Urban District of Ufa, Bashkiria
Kamalov E.M.
Signature
Official Seal
October 5th, 2009
Clinical Trials Certificate for TREATMENT EFFICACY of DETA-13 APPARATUS
2009
Reason for conducting the research: The post-approval clinical testing Contract dated March 28th,
2009.
The Research Objective: Estimate a possibility of using DETA-13 apparatus manufactured by “ELIS”
LLP SPE in medical practice within the territory of the Russian Federation when treating gynecopathies
associated with carrier state of urinogenital infections: clamidiosis, ureplasmosis, mycoplasmosis,
gardnerellosis, candidosis, and cytomegalovirus, herpetic and toxoplasmatic infections.
Type of the Research: unmasked, nonrandomized, comparative.
The Research Tasks:
1. Determine the clinical efficacy of using DETA-13 apparatus when treating delitescent carrier
state and recrudescence of chronic forms of urinogenital infections in the capacity of
monotherapy.
2. Research the clinical efficacy of using DETA-13 apparatus when treating the acute types of
infectious inflammatory diseases of genital organs associated with sexually transmitted diseases,
as a part of comprehensive treatment.
3. Estimate the safety of using DETA-13 apparatus when treating the above-mentioned diseases.
The Research Plan:
The Research includes the reproductive age (18-42 years) women treated on an outpatient basis in
the Gynecology Department of the Urban Perinatal Centre as well as the female patients
registered in the Municipal Center for Family Planning and Reproduction.
Patients have been selected in accordance with the chosen inclusion criteria.
Inclusion Criteria: The research includes the female patients with clamidiosis, ureaplasmosis,
mycoplasmosis, gardnerellolsis, candidosis, and cytomegaloviral, herpetic and toxoplasmatic infections,
substantiated by data of blood enzume immunoassay and PCR on swab, the female patients suffering
from chronic and acute inflammatory diseases of female genital area and the female patients having the
aggravated history in regard to habitual noncarrying of pregnancy and sterility.
Examination and treatment have been carried out on the basis of the informed voluntary patient consent
on an Order №163 (All-Union standard 91500.14.0001-2002) of Ministry of Health of the Russian
Federation. Experimentation has been agreed upon with the Local Ethical Committee.
The place and time of the research: Gynecological Department of the Municipal Medical and Preventive
Treatment Institution of the Maternity Hospital № 4 of Ufa
The following has been provided for the research:
1. DETA-AR 13 and DETA-Ritm-13 apparatus manufactured by “ELIS” LLP SPE (Moscow) in amount of 3
ea; the apparatus software provides the antiparasitic and restorative electromagnetic wave therapy.
2. DETA-13 apparatus is allowed to be applied in medical practice (marketing authorization of
Roszdravnadzor № FS 022 а1710/4625-06 dated December 22nd, 2011).
3. DETA-13 apparatus Operating Manual.
4. Guidelines for using DETA-13 apparatus.
Technique of diagnostics and treatment by means of wave therapy is covered by patent №2000114578 dated
March 20th, 2003, on legal grounds used by “ELIS” LLC SPE
The Research Results:
Over the period from July 27th, 2009 till October 4th, 2009 the clinical efficacy research of different correction
ways of gynecopathies associated with a carrier state of urogenital infections: clamidiosis, ureaplasmosis,
mycoplasmosis, gardnerellosis, candidosis, and cytomegaloviral, herpetic and toxoplasmatic infections, has been
carried out among 16 patients (women), at the age of 18 to 42 years old (mean age is 29.3±1.0 years old).
The disease diagnosis has been clinically established with confirmation of enzyme multiplied immunoassay
data and fragment detection of pathogen DNA by means of PCR in discharge of the lower sections of genitourinary
system.
The basic group has been divided into 2 subgroups: the first group received therapy from DETA-13 apparatus
only; the second group received a combination of drug and bio-resonance therapy.
The control group (a drug treatment only) amounted to 15 persons (women) at the age of 18 to 42 years old
(mean age is 26.3 ± 1.1 years old).
Study groups have been collated according to the age, nosological entities and basic disease severity.
The treatment technique. DETA-13 apparatus setting-up procedures have been made as directed by the
apparatus operating manual before treatment procedure. Apparatus switching-on and switching-off have been made
as directed by this manual. In the course of session the apparatus was located in the nidus focalization plane of the
female patient. Duration of procedure depended on the individual program set, from 50 up to 240 minutes, 90-120
minutes on average. Frequency is 1-2 sessions per day depending on the procedure tolerability; the course is from 5
up to 10 days.
A necessity of the concomitant drug therapy in the basic group has been determined according to a severity of
patient’s condition. Detoxification fluid and antibacterial therapy has been conducted among the female patients
with acute types of the infectious inflammatory diseases in case of the frank intoxication symptoms.
The bio-resonance therapy has been conducted in case of moderately frank intoxication, low and average degree of a
disease severity.
Estimation of medical efficiency of the applied methods has been conducted by means of the daily clinical
examinations including an overall condition estimate, thermometry, special pelvic examination. Ultrasonic
examination has been conducted once every three days, complete blood count with
determination of WBC differential, erythrocyte sedimentation rate, leucocytic intoxication
index. Vaginal microbiocenosis has been examined before and after treatment by means of the
light microscopy and bacteriological examination. Its efficacy was confirmed by means of PCR
and enzyme immunoassay in 1.5-2 months after the end of the treatment.
Clinical supervision over the patients, who received the treatment from DETA-13 apparatus
in the capacity of monotherapy and the treatment combined with drug therapy, allowed to reveal
more pronounced positive therapeutic effect in comparison with the control group that received
antibiotics, fluid therapy and anti-inflammatory therapy.
The treatment efficacy has been expressed in decreasing of intoxication effects
(normalization of temperature, CBC indexes, local state). Elimination of the pain syndrome
among the patients of the basic group occurred by the 2nd – 3rd day i.e. 2.5 times as fast as in the
control group.
It has been revealed that there was no any need for sequential elimination of causative
organisms for treating the above-mentioned infections at this stage of the post-approval clinical
testing. It is possible to use programs concurrently (at the same day) for 3-5 revealed viruses and
bacteria. Therapy is well tolerated and doesn’t cause aggravation of the patient’s cenesthesia and
frank intoxication requiring a medicamental correction.
Clinical profile of the study groups and influence of various modalities of the treatment of inflammatory
pelvic diseases are described in Table 1.
Table 1.
Diagnosis
Aggravation of chronic
endometritis, salpingooophoritis against the
background of carrier
state of:
Clamidiosis
Ureaplasmosis
Mycoplasmosis
CMV
HSV
Quantity of Patients
Basic
Group
Control
Group
Average
duration of
traditional drug
therapy in the
control group
Average
duration of
treatment using
DETA
apparatus in
the basic group
(days)
N=16
N=15
11.3±0.2
6.3±0.1
Average
duration of
treatment using
DETA
apparatus in
combination
with drug
therapy in the
basic group
(days)
6.1±0.2
11
14
11
15
15
12
11
10
15
15
12.3±0.3
10.3±0.2
8.2±0.1
14.3±0.3
13.7±0.3
7.8±0.2
6.7±0.2
6.9±0.2
5.3±0.1
5.2±0.1
7.1±0.2
6.1±0.1
6.3±03
5.2±0.1
5.3±0.2
Tolerability. It is important to note an ease and good tolerability of therapy by DETA-13
apparatus, absence of constitutional and local adverse reactions when treating gynecopathies
associated with carrier state of urinogenital infections: clamidiosis, ureaplasmosis,
mycoplasmosis, gardnerellosis, candidiasis, and cytomegaloviral, herpetic and toxoplasmatic
infections.
Therapy did not exert a negative influence on the process of somatic co-morbidity possessed by patients
under observation. Moreover an application (in comprehensive therapy) of DETA-Ritm-13 apparatus and
recovery frequencies selected in antiparasitic programs for DETA-AR-13 apparatus aids in faster
recovery of anatomy and functions of affected organs.
Efficacy of treatment of the chronic endometritis, associated with inadequate increasing (hypoplasia)
of endometrium in the course of menstrual cycles and ovulation induction cycles among 7 patients with
the help of DETA-13 apparatus, which often is the main cause of sterility and habitual noncarrying of
pregnance, is confirmed by data of hysteroscopy and timed endometrial biopsy as well as ultrasonic cycle
monitoring.
Conclusion.
1.
DETA-AR-13 and DETA-Ritm-13 (with software) has the functional and operating
characteristics which fully meet requirements of medical practice in the area of the gynecopathy
treatment.
2.
High clinical performance of DETA-13 apparatus is revealed both in the form of
monotherapy and together with drug therapy when treating the chronic and acute pelvic
inflammatory diseases associated with carrier state of urogenital infections, in comparison with
the traditional treatment methods.
3.
Contraindications on using DETA-13 apparatus have not been revealed among patients.
4.
It is possible to use DETA-13 apparatus on an outpatient, inpatient basis and at home.
Recommendations
Head Physician
Signature
Candidate of Medical Science, E.M. Kamalov
Signature
Candidate of Medical Science, T.V. Saubanova
Official Seal
Executive Manager