"APPROVE"
The Pro-rector on Science Moscow Medical Academy Named after Sechenov doctor of medical science, professor S.V. Grachev |
"APPROVE"
The Head of Endocrinology & Diabetology Chair Moscow Medical Academy Named after Sechenov doctor of medical science, professor M.I. Balabolkin |
S U R V E Y
of clinical test on influence
of Autonomous Electrostimulator of Gastrointestinal Tract And Mucosa -
"Electronic Normalizer"
on carbohydrate and lipide metabolism
and on secretory function of
some endocrine glands
At the chair of Endocrinology and Diabetology of Post-Graduate Study Faculty of Moscow Medical Academy named after I.M.Sechenov, on programs coordinated with Research & Production Association "Ecomed" in 1995-1996, clinical tests of influence of autonomous electrostimulators of gastrointestinal tract and mucosa - the Electronic Normalizer produced by Research and Production Association "Ecomed" on metabolic processes and secretory functions have been conducted.
The purpose of the present tests was the analysis of influence of electrostimulator -the Electronic Normalizer on the condition of carbohydrate and lipide metabolism as well as on function of some peripheral endocrine glands. Our previous tests showed that in opened monitored test electrostimulator practically normalizes lipide metabolism of people, suffering from diabetes mellitus of first type (achrestic) and of second type (insulin-independent diabetes). The conducted tests have shown that patients suffering from both achrestic and insulin-independent diabetes on the 30-th day after taking the capsule of the electrostimulator - the Electronic Normalizer (produced by Research & Production Association "Ecomed") were marked with the certain decrease of initially heightened level of cholesterol, triglycerides, lipoproteins of low density at simultaneous increase of the level of lipoproteins of high-density.
Despite of it there are problems left regarding the effect duration and residual effect of the electrostimulator - the Electronic Normalizer as regards to lipide metabolism and possible participation of endocrine system in lipide decreasing effect of the electrostimulator -the Electronic Normalizer. Besides, it was necessary to eliminate the possibility of other factors (psychological etc.) influence while investigating the effect of the electrostimulator - the Electronic Normalizer. With this purpose and under recommendation of the academician Å.I.Chazova it was decided to analysis the influence of the Electronic normalizer capsules under double blind method.
At first 95 people with diabetes mellitus were examined beside carbohydrate metabolism indices for presence in their blood serum of cholesterol, triglycerides, cholesterol of lipoproteins of high and low density, creatinine, urea, bilirubin, alkaline phosphatase, potassium, natrium, phosphorum, blood protein, glucose in blood and urine. Bulk analysis of their blood and urine was made as well.
After primary examination it was advised to include in the group of further observation the patients with different degree of disturbance of lipide metabolism provided absence of acute processes in liver, hepatocirrhosis and chronic renal insufficiency.
Finally there were selected 20 patients suffering from diabetes mellitus of II type. They were informed of the terms of tests conducting and they gave their consent to participate. The selected patients had different degree of expressiveness of lipide metabolism disturbance.
After randomization the patients were divided into two groups, 10 men in each (first group - 2 men and 8 women; second group - 3 men and 7 women). The age of the examined 43-66-year-old women averaged 56,4 ± 7,5; the age of the examined 45-69-year-old men averaged 53,2 ± 7,3. The duration of disease for the women was 1-22 years and averaged 10,13 ± 3,18 years and for the men - 2-16 years, on the average - 9,8 ± 3,1 years.
After thus selected patients have entered the hospital their full clinical examination was conducted:
Biochemical and hormonal indices were examined before taking the capsule the Electronic Normalizer and 30 days after. This very day (after blood for examination has been taken) the patients were given the second capsule the Electronic Normalizer. 30 days after (or on the 60-th day after taking the first capsule) the above listed biochemical and hormonal analysis of blood was again made.
The patients apropos their basic disease have been taking different sugar decreasing preparations: pelleted - maninilum, diabetonum or glurenorm, and some patients with achrestic form of diabetes mellitus- peroral preparations combined with insulinization.
20 working units of the electrostimulator - the Electronic Normalizer (TU 9444-014-11555014) and 20 placeboes were used during tests conducting.
  | Senior lecturer of the Chair, Candidate of Medical Sciences       |
(signature)   |
À.Ìkrutumyan   |
  | Intern of the Chair | (signature) | V.Kreminskaya |