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Geptrong – clinical trials results and experimental data - Начало

Background
The natural honey consisted of carbohydrates (monosaccharides – dextrose, fructose and disaccharides – sucrose), proteins (apamin, mellitene), enzymes (invertase, catalase, hyaluronidase, phospholipase A, acid phosphatase), minerals (Calcium salts, Sodium, Magnesium, Iron, sulfur, iodine, chlorine, phosphorus), micronutrients (manganese, silicon, aluminum, boron, chromium, copper, nickel, lead, tin, zinc, magnesium, fluorine), organic acids (malic acid, tartaric acid, citric acid, lactic acid, oxalic acid, formic acid), vitamins (B2, B6, PP, C, K, E, folic acid), essential/volatile oils, staining agents (carotin), water, biogenic stimulators, growth regulator, etc.
The naturally occurring honey solutions currently implemented in medicine have limited efficacy. Moreover, naturally occurring honey solutions are painful, results in injection site infiltration poorly resolved.
WHO reports over 450 millions chronic hepatitis worldwide including the developed countries, with strict grow tendency. The same pattern observed for alcohol, drug, and toxic hepatitis. Total 66% of population suffers liver affection.

The results of controlled clinical trial phase II: Efficiency and safety of a preparation the Geptrong in patients with acute viral hepatitis A, acute and chronic viral hepatitis B, chronic hepatitis C.
The purpose of research was the estimation of efficiency and safety of application of a preparation the Geptrong in the form of an injection solution in comparison with traditional metabolic therapy at treatment of patients by a viral hepatitis
Research of a clinical phase II was carried out on simple blind a placebo controllable in stationary conditions on clinical bases of four medical institutes.
The clinical hospitals of Pharmacological committee which are implemented clinical trial:

  • Faculty of infectious diseases TIPME, Director, Professor. E.I. Musabaev
  • Faculties of infectious and tropical illnesses TSMI II, Acting head, Assistant professor M.T. Karimova
  • Faculty of infectious diseases TPMI, Director, Professor I.A. Kasymov
  • Scientific research institute of Epidemiology, microbiology and infectious diseases, Director, Professor M.D. Akhmedova.
Treatment was supervised by traditional metabolic therapy where instead of preparation the patients have been treated with equivolume quantity of normal saline solution (NaCl 0.9%). Traditional metabolic therapy included the diet, infusions of glucose, Hemodez®, Reopoliglukin®, vitamins of group B and C, Asparkam®, Riboksin®, calcium chloride, vegetative choleretic species, cleaning enemas.
Duration of treatment and supervision was not less than 14 weeks.
In research patients with the replicative form of acute viral hepatitis A (AVAH), an acute viral hepatitis B (AVBH), chronic viral hepatitis B (CVBH), chronic viral hepatitis C (CVCH) have passed randomization and participated estimated totally of 188 persons. 94 patients formed study group, 94 - control group.

The therapy design

alt

Criteria of safety and tolerance assessment of Geptrong:

  • revealing of the possible adverse affects
  • clinically significant changes of laboratory parameters
  • assessment of vital functions (blood pressure, pulse)
  • Assessment of tolerance by the patient and physician.

Results

Middle age of patients estimated 18-41 years, men/women ratio – 100/88. Severity of viral affection of liver in patients in research was estimated on the basis of expressiveness of clinical signs and biochemical parameters. Distribution of patients on severity viral hepatitis depending on the etiological agent is submitted below

Table 1

Distribution of patients with viral hepatitis depending on degree of activity of disease, n (%)

chronic viral hepatitis B

chronic viral hepatitis C

Study group

(n=19)

Control Group

(n=17)

Study group

(n=11)

Control Group

(n=11)

Minimal

5 (26.3)

5 (29.4)

6 (54.5)

7 (63.6)

Mild

10 (52.6)

9 (52.9)

4 (36.4)

3 (27.3)

Moderate

3 (15.8)

2 (11.8)

1 (9.1)

1 (9.1)

Expressed

1 (5.3)

1 (5.9)

-

-

Apparently patients with the moderate-severe form of disease prevailed.

Assessment of efficiency of Geptrong

The estimation of efficiency of three-week use of the medical complex including Geptrong, was based on terms of achievement of clinical-biochemical remission: reduction of painful abdominal, dyspeptic syndromes, attributes of cholestasis, intoxication, normalization of ALT, AST, AP, common bilirubin, thymol (turbidity) tests in compared groups.

Additional criteria were terms of seroconversion of PCR HBV (-) in AVBH, seroconversion in CVBH (PCR HBV (-)) and CVCH (PCR HСV (-)) in groups of comparison, and dynamics of activity of inflammatory changes according to puncture biopsy of liver.

Clinical efficiency of therapy by Geptrong in patients with viral hepatitis

Actually clinical inspection of patients included an estimation of complaints, the anamnesis of illness and a life, character of an accompanying pathology, the data of objective research.

The estimation of expressiveness of clinical signs at patients with a viral hepatitis was made dynamically (daily). Duration of existence of symptoms differed at patients of study and control groups. Most distinctly it the analysis of clinical signs for 21 day of research (the termination of treatment), revealed has shown distinctions in preservation of some symptoms and syndromes between groups of the patients treated by traditional metabolic therapy and patients, receiving a preparation the Geptrong. The received data are submitted below

Table 2

Clinical symptoms in patients with viral hepatitis by 21 day of research (the termination of treatment)

Acute viral A hepatitis

Acute viral B hepatitis

Chronic viral B hepatitis

Chronic viral C hepatitis

Study group (n=6)

Control group (n=6)

Study group (n=26)

Control group (n=26)

Study group (n=38)

Control group (n=38)

Study group (n=24)

Control group (n=24)

Jaundice

-

-

3 (11.2)

5 (19.2)

4 (10.5) *

11 (28.9)

-

1 (4.2)

Icteriousness of sclera

-

1 (16.7)

3 (11.2)

5 (19.2)

4 (10.5)*

9 (23.7)

1 (4.2)*

4 (16.7)

Darkening of urine

-

-

3 (11.2)

4 (15.4)

3 (7.9)

4 (10.5)

-

2 (8.3)

Liver enlargement

-

-

-

4 (15.4)

2 (5.3)*

12 (31.6)

-

4 (16.7)

Spleen enlargement

-

-

-

4 (15.4)

3 (7.9)*

8 (21.1)

3 (12.5)*

6 (25.0)

Decrease in appetite

-

1 (16.7)

3 (11.2)

5 (19.2)

4 (10.5)

4 (10.5)

-

3 (12.5)

Eructation

-

-

-

2 (7.7)

3 (7.9)*

7 (18.4)

3 (12.5)

3 (12.5)

Flu like syndrome

-

-

3 (11.2)

4 (15.4)

4 (10.5)

5 (13.2)

1 (4.2)

2 (8.3)

Asthenovegetative syndrome

-

2 (33.3)

1 (3.8)*

12 (46.2)

3 (7.9)*

21 (55.3)

-

13 (54.2)

* - distinctions with control group are statistically authentic (р> 0.05)

Thus, on a background of study therapy by the moment of the termination of treatment in the greater number of supervision, in comparison with the control, regress of clinical attributes dyspeptic was marked; cholestasis and asthenovegetative syndromes, the hepatomegaly and hypersplenism practically were completely ceased with absence of distinctions in dynamics of displays of flu like syndrome.

Estimation of biochemical efficiency of study therapy in patients with viral hepatitis

Dynamics of activity of ALT in patients with hepatitis of viral etiology during treatment with use of Geptrong in comparison with the patients receiving only metabolic therapy is shown below:

Table 3

Average activity of ALT in patients with viral hepatitis during treatment

Acute viral A hepatitis

Acute viral B hepatitis

Chronic viral B hepatitis

Chronic viral C hepatitis

Study group (n=6)

Control group (n=6)

Study group (n=26)

Control group (n=26)

Study group (n=38)

Control group (n=38)

Study group (n=24)

Control group (n=24)

1 day

4.4±0.5

4.0±0.7

4.9±0.8

4.6±1.0

2.3±0.7

2.1±0.6

2.1±0.6

1.7±0.6

21 day

1.2±0.4

1.4±0.5

2.4±0.8

2.7±0.9

1.4±0.5

1.7±0.6

1.4±0.5

1.7±0.6

Discharge

0.8±0.3

1.0±0.3

1.0±0.3

1.5±0.5

1.1±0.4

1.2±0.4

0.9±03

1.2±0.4

Average ALT figures in patients during treatment were reduced: in 4 times in study group and in 2.5 times in control group. By the moment of discharging patients of study group normalization of parameter and in the control the tendency to normalization were obtained.

Similar tendencies but with less expressed distinctions were dynamics of activity of AST.

Table 4

Dynamics of average activity of AST in patients with viral hepatitis during treatment

Acute viral A hepatitis

Acute viral B hepatitis

Chronic viral B hepatitis

Chronic viral C hepatitis

Study group (n=6)

Control group (n=6)

Study group (n=26)

Control group (n=26)

Study group (n=38)

Control group (n=38)

Study group (n=24)

Control group (n=24)

1 day

2.3±0.5

1.8±0.4

2.4±0.7

2.1±0.5

2.0±0.6

1.0±0.3

1.7±0.4

1.1±0.3

21 day

0.5±0.2

1.3±0.6

1.2±0.6

1.6±0.5

0.7±0.4

1.4±0.4

0.6±0.3

1.0±0.7

Discharge

0.5±0.1

1.0±0.4

0.7±0.4

1.1±0.4

0.6±0.3

1.2±0.4

0.5±0.2

0.9±0.5

Expressiveness of cytolysis and inflammatory syndromes correlates with intensity of laboratory values of cholestasis syndrome. The dynamic assessment has been made on increasing result of levels of bilirubin and AP (alkaline phosphatase).


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