REPORT on the results of clinical study of peptide bioregulator Stamakort

Written by KHAVINSON, Ph.D., Vladimir

Translated from Russian

                     “APPROVED BY”

Director of the Medical Center

of Saint Petersburg Institute of Bioregulation and Gerontology of the Northwest Branch of the Russian Academy of Medical Sciences,

corresponding member of the Russian Academy of Sciences, professor,   

Doctor of Medical Sciences

 

                                                       _________________________V.H. KHAVINSON

 

                                                           «______»___________________2011

 

 

 

 

REPORT

on the results of clinical study

of biologically active food additive

Stamakort®

  

 

 

        Saint Petersburg

2011

 

Biologically active food additive Stamakort contains a complex of low-molecular peptides with molecular weight up to 5000 Da, isolated from gastric mucosa of young animals – calves up to 12 month of age or pigs.  

            Stamakort is manufactured in the form of capsules with active substance content 10 mg.

Chronic inflammatory diseases of stomach and duodenum, postoperative complications are a typical reason of formation of functional insufficiency, disorders of secretory and motor functions of different parts of gastrointestinal tract (1,2,3), considerably decreasing quality of life of the people of various age.

            Drug treatment of the diseases and pathological conditions includes administration of the following medicines (2, 3):

            – enzyme preparations, which improve digestion (pepsin, panzinorm, mezym forte, festal).

            – amarines (centaury herb, absinthium herb, dandelion root);

            – ganglionic blockers (hexonium, methacynum);

            – polyvitamins;

            – biostimulators (aloe);

            – etc.

Clinical study of Stamakort was carried out at the Medical center of Saint Petersburg Institute of bioregulation and gerontology during the period from February till August 2011.

The clinical studies of Stamakort included 47 patients with chronic gastritis, who were complaining of feeling of heaviness and fullness in epigastrium, abdominal distension, food or air eructation, abdominal murmur, stool disorders, general weakness.  They have periodic dull, aching pain in anticardium after meal.  Distribution of patients by sex and age is stated in the table 1.

            All the patients had symptomatic and pathogenetic therapy earlier on the occasion of the diseases.

 The patients were randomly divided into 2 groups. Control group included 17 patients with generally accepted therapy.

Patients of the basic group (30 persons) in addition to the general therapy have been taking Stamakort – 1-2 capsules 3 times a day 10-15 minutes before meal for 30 days depending on pathological process intensity.

 

 

 

 

 

                                                                                                                        Table 1

Distribution of patients by sex and age

Diagnosis

Age

(years)

Group

Men

Women

Total:

Chronic gastritis with secretory insufficiency

36-72

Control

10

7

17

35-70

Basic

19

11

30

Total:

 

 

29

18

47

 

Methods of examination

            We have been evaluating complaints of the patients, carried out general clinical blood analysis, and urine analysis, biochemical blood analysis using “REFLOTRON” device (Boehringer Mannheim, Germany). We have performed determination of secretory function of stomach and fiberoptic gastroscopy.

Results of examination

 

            As a result of carried out examination is was established that administration of Stamakort resulted in smoothing of clinical signs of the chronic gastritis in 86% of cases, thus the maximum effect was observed in the older persons with signs of atrophic changes of gastric mucosa at the fiberoptic gastroscopy. 

            Laboratory tests of the gastric acid has shown insufficient secretion of stomach in the examined patients of both groups before treatment (table 2).

Parameters of general acidity and free hydrochloric acid in patients of both groups before treatment were at the lower limit of normal ranges with clinical signs of decreased acidity.  After treatment using general methods parameters of general acidity and free hydrochloric acid in patients of control group have increased accordingly from 24,2±2,1 mmol/l up to 31,4±2,4 mmol/l, and in patients of the basic group – up to до 37,1±1,8 mmol/l, which is reliably higher than the parameters in the control group (p<0,05). The same tendency was observed when studying the dynamics of changes of the parameter of content of free hydrochloric acid. As a result of action of Stamakort, we have noticed optimization of the parameters of gastric secretory function in patients of the basic group, because the parameters of general acidity and free hydrochloric acid approached the normal values.

 

 

 

Table 2

Influence of Stamakort on secretory function of stomach in patients with

 chronic gastritis

 

Parameters

Before treatment

After treatment

Control group

(basic group)

Control group

(basic group)

Total acidity on an empty stomach, mmol/l

24,2±2,1

22,6±1,7

31,4±2,4*

37,1±1,8*#

Free HCl, mmol/l

11,3±1,1

14,3±1,7

15,9±1,3*

19,2±1,5*

Debit HCl, mmol/l

1,21±0,08

1,13±0,01

1,57±0,05

1,86±0,03

Debit of free HCl, mmol/l

0,56±0,03

0,72±0,04

0,79±0,07

0,96±0,04

            * р<0,05 – in comparison with the parameter in the same group before treatment;

            ** р<0,05 – in comparison with similar parameters in the control group.

 

            At analysis of the composition of the gastric juice during Stamakort administration in patients of the basic group we have noticed an increase in the gastric acidity, decrease in inflammatory changes of gastric mucosa, there was a decrease in the amount of mucus and food debris in the analyzed portions, which is a signs of increased secretory and evacuation function of the stomach.

The patients have notices clinical changes – decrease in dyspeptic disorder, decrease in pain syndrome, health improvement.

            It is evident, that normalization of digestion in patients with chronic gastritis was related to regulatory influence of Stamakort not only on the functions of gastric and duodenal mucosa cells, but on stimulation of enzymatic activity of the duodenal content.

            Thus the results obtained confirm efficiency of Stamakort and expedience of its application for complex treatment of chronic gastritis.

            Stamakort does not result in any side effects, complications and drug dependence.

            Stamakort can be used for treatment and prophylactic in the form of biologically active food additive together with any means of symptomatic and pathogenic therapy, used for treatment of chronic gastritis.

 

 

 

 

Conclusion

            Biologically active food additive Stamakort normalizes metabolism in the gastric mucosa tissues.

            Stamakort is well tolerated at oral administration, does not have any side effects and can be used as treatment-prophylactic biologically active food additive.

            Stamakort is recommended to patients with chronic gastritis – per os 1-2 capsules 2-3 times a day 10-15 minutes before meal for 15-30 days depending on pathological process intensity.

            It is recommended to carry out repeated courses of treatment every 3-6 month.

            It is expedient recommending Stamakort for treatment and prevention application and industrial production.

References

  1. Belousov Y.B., Moiseev V.S., Lepakhin V.K. Clinical pharmacology and pharmacotherapy: Manual for doctors. – М.: Universum, 1993. – 398 pages.
  2. Mashkovsky M.D. Medicines: Pharmacotherapy manual for healthcare professionals: 2 parts – Vilnus: ZAO “Gamta”, 1993.
  3. Geriatrics manual / Edited by D.F. Chebotarev, N.B. Mankovsky. – М.: Medicine, 1982. – 544 pages.

 

 

Recommendations for use

     Stamakort is a complex of peptides, received from gastric mucosa of young animals.  The isolated peptides have selective effect on various cells of gastric mucosa tissues, they normalize metabolism in corresponding cells and regulate their functions. 

The clinical study has helped to establish an efficiency of Stamakort for complex restoration of the functions of the digestive system after diseases of various origin, at pathological conditions, resulting in stomach dysfunction, at influence of extreme environmental factors, hypoalimentation, and at ageing.

 

Stamakort should be taken per os at mealtime 1-2 capsules 1-2 times a day.  The period of administration makes 30 days.  It is reasonable to have a repeated course in 4-6 month.

        Contraindications: individual intolerance to the components, pregnancy, breast feeding.

Administration of Stamakort has not resulted in any side effects.

It is recommended to store in a dry dark place at the temperature from +2 up to +25ºС.

Pharmaceutical form: 20 capsules or tablets of Stamakort 10 mg each.

         Period of validity – 5 years from the day of manufacturing.

 

Executive officer:

Deputy Director of LLC “Medical Center of Saint Petersburg Institute of Bioregulation and Gerontology of the Northwest Branch of the Russian Academy of Medical Sciences” in charge of clinical affairs, Ph.D., assistant professor

 

 

 

 

________________________A.A. Veretenko

 

Action officer:

Chief Physician of LLC “Medical Center of Saint Petersburg Institute of Bioregulation and Gerontology of the Northwest Branch of the Russian Academy of Medical Sciences”, Ph.D.

 

 

 

 

 

_____________________O.Y. Raygorodsky