APPROVED BY
Rector of the State Educational Institution
of Higher Professional Learning of Nizhny
Novgorod State Medical Academy
Professor Shakhov B. E.
Signature
th
September 4 2009
Official Seal
Clinical Trials Certificate for TREATMENT EFFICACY of DETA-AR APPARATUS when
treating PELVIC INFLAMMATORY DISEASE (acute and chronic forms) in gynecology
2009
Reason for conducting the research: The post-approval clinical testing Contract dated November 7th,
2008.
Research Objective: determine a therapy efficacy of “DETA-AR” apparatus among patients with
PELVIC INFLAMMATORY DISEASE, associated with chlamydiaes, mycoplasmas, ureaplasmas, CMV
infection, herpetic infection, HPV infection.
Type of Research: unmasked, nonrandomized, comparative.
Research Tasks:
1. Determine the clinical efficacy of traditional antibacterial and antiviral therapy among patients
with PELVIC INFLAMMATORY DISEASE, associated with chlamydiaes, mycoplasmas,
ureaplasmas, CMV infection, herpetic infection, HPV infection.
2. Research the clinical efficacy of DETA-AR apparatus among patients with PELVIC
INFLAMMATORY DISEASE, associated with chlamydiaes, mycoplasmas, ureaplasmas, CMV
infection, herpetic infection, HPV infection in the capacity of an additional treatment method in
combination with traditional antibacterial and antiviral therapy.
3. Determine the clinical efficacy of DETA-AR apparatus among patients with PELVIC
INFLAMMATORY DISEASE, associated with chlamydiaes, mycoplasmas, ureaplasmas, CMV
infection, herpetic infection, HPV infection in the capacity of monotherapy.
4. Estimate the safety of DETA-AR apparatus when treating above-mentioned diseases.
Research Plan:
Research includes the reproductive age (18-42 years) women treated on an outpatient basis in the
maternity welfare centre № 10 of Medical and Preventive Treatment Institution of “Maternity
Hospital № 4”.
Patients have been selected in accordance with the chosen inclusion criteria.
Inclusion Criteria: Research includes the patients with PELVIC INFLAMMATORY DISEASE
(acute and chronic forms), associated with chlamydiaes, micoplasmas, ureaplasmas, CMV infection,
herpetic infection, HPV infection,
substantiated data of blood enzume immunoassay and PCR on swab, suffering from chronic and acute
inflammatory diseases of female genital area.
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 of the State Health
Care Institution of Nizhniy Novgorod District Clinical Hospital n.a. N.A. Semashko.
The place and time of experimentation: the maternity welfare centre № 10 of Medical and
Preventive Treatment Institution of “Maternity Hospital № 4” of Nizhniy Novgorod from November
7th, 2008 till December 1st, 2009.
The following has been provided for experimentation:
1. DETA-AR apparatus manufactured by “ELIS” LLC NPO (Moscow) in amount of 3 ea; apparatus
software provides the antiparasitic electromagnetic wave therapy.
2. DETA-AR apparatus is allowed to be applied in medical practice (marketing authorization of
Roszdravnadzor № FS 022 а 1710/4625-06 dated December 22nd, 2011)
3. DETA-AR apparatus Operating Manual.
4. Guidelines for using DETA apparatus. Diagnostics and treatment technique is covered by patent
№2000114578 dated March 20th, 2003, on legal grounds used by “ELIS” LLC NPO.
The Research Results:
The clinical efficacy research of different correction ways of Pelvic Inflammatory Disease caused by
chlamydiaes, mycoplasmas, ureaplasmas, cytomegaloviral, herpetic and HPV infection has been carried
out among 45 patients (women), at the age of 18 to 42 years old (mean age is 29.3 ±1.1 years).
The disease diagnosis is clinically established with confirmation of enzyme multiplied immunoassay
data and fragment detection of pathogen DNA by means of PCR.
Basic group has been divided into 2 subgroups:
1st (N1) – combination of drug and bio-resonance therapy.
2nd (N2) received a therapy from DETA-AP apparatus only,
Control group (N3) (drug therapy only) amounted to 55 persons (women), at the age of 18 to 42 years
old (mean age is 26.3 + 1.2 years).
Study groups have been collated according to age, nosological entities and basic disease severity.
The treatment technique. DETA apparatus setting-up procedures have been made as directed by the
apparatus operating manuals 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, on average is 40-60 minutes. All the patients of basic group
received 3 sessions of bio-resonance therapy every other day and 3 sessions of
detoxification bio-resonance therapy.
Estimation of medical efficiency of applied methods has been conducted by means of the
clinical examinations once every other day including an overall condition estimate,
thermometry, special pelvic examination (before and after the full course of therapy), at
the beginning and at the end of the therapy: ultrasonic examination of pelvic organs,
CBC with determination of WBC differential, erythrocyte sedimentation rate,
leucocytic intoxication index, vaginal microbiocenosis before and after the treatment by
means of the light microscopy and bacteriological examination.
Clinical supervision over the patients, who received treatment from DETA-AR apparatus in
the capacity of monotherapy and therapy combined with drug treatment, allowed to
reveal more pronounced positive therapeutic effect in comparison with the control
group that received the standard antibacterial and antiviral therapy. The treatment
efficacy has been expressed in normalization of temperature, CBC indexes OAK, local
state. Elimination of the pain syndrome (the persistent dull aching pains at the
abdominal bottom) among the patients of the basic group occurred by the 2nd day i.e.
three times as fast as in the control group.
Clinical profile of the study group and influence of the various treatment modalities of
inflammatory disease of pelvic organs are described in Table 1.
Table 1.
Diagnosis
Quantity of
Average duration of
Average duration of Average duration of
Patients
treatment when
monotherapy using
treatment using the
DETA-AR apparatus traditional drug
N1 N2 N3 combining the drug
and bio-resonance
therapy
therapy
Clamidiosis
6
2
10 12.2±1.4
14.53±1.7
3±0
Mycplasmosis 3
2
9
7.23±1.1
3±0
8±1.3
Ureaplasmosis 6
2
10 8.93±0.9
3±0
9.33±1.1
CMV infection
6
3
8
10.73±1.2
3±0
12.23±1.5
HPV infection 5
3
10 14.43±1.3
3±0
15.93±1.3
Herpes virus
4
3
8
21.3±2.7
3±0
24.53±3.0
Tolerability. It is important to note an ease and good tolerability of therapy of DETA-AR
apparatus, absence of constitutional and local adverse reactions when treating the Pelvic
Inflammatory Disease associated with the presence of chlamydiaes, mycoplasmas,
ureaplasmas, cytomegaloviral, herpetic and papilloma virus infection.
Therapy did not exert a negative influence on the process of somatic co-morbidity possessed by patients
under observation. Moreover an application of recovery frequencies selected in antiparasitic programs of
DETA-AR apparatus aids in faster recovery of anatomy and functions of affected organs.
Conclusion.
1. The insufficient clinical efficacy of traditional antibacterial and antiviral therapy has been
revealed among patients with Pelvic Inflammatory Disease associated with chlamydiaes,
mycoplasmas, ureaplasmas, CMV infection, herpetic infection, HPV infection (60-65%).
2. High clinical performance of DETA-AR apparatus is revealed both together with traditional drug
therapy of Pelvic Inflammatory Disease associated with chlamydiaes, mycoplasmas,
ureaplasmas, CMV infection, herpetic infection, HPV infection (87-92%) and in the capacity of
monotherapy of these infections (85%).
3. Absence of contraindications on using DETA-AR apparatus is revealed among patients with
Pelvic Inflammatory Disease associated with chlamydiaes, mycoplasmas, ureaplasmas, CMV
infection, herpetic infection, HPV infection.
4. It is possible to use “DETA-AR” apparatus on an outpatient, inpatient basis and at home.
Manager:
Doctor of Medical Science, Professor
Head of Obstetrics and Gynecology Department of
Advanced Training Faculty of the State Educational
Institution of Higher Professional Learning of Nizhny
Novgorod State Medical Academy
Signature
L.V. Borovkova
Executive Manager:
Candidate of Medical Science, Assistant of Obstetrics
and Gynecology Department of Advanced Training
Faculty of the State Educational Institution of Higher
Professional Learning of Nizhny Novgorod State Medical
Academy
Signature
D.V. Pershin
Senior Physician of Medical and Preventive
Treatment Institution of “Maternity Hospital
№ 4” of Nizhniy Novgorod
Institution Seal
Signature
A.V. Egorov