This study evaluates the dietary and therapeutic effect of supplement consisting of sublimated mare milk among patients with non-alcoholic steatohepatitis.
Nonalcoholic steatohepatitis (NASH) is characterized by the liver damage in the form of fatty degeneration and hepatitis in people who do not abuse alcohol. The disease often develops in middle-aged women with excessive body weight, increased blood glucose and blood lipids, but can occur in all age groups and in both sexes. In most cases, the disease is asymptomatic. Laboratory data indicate an increase in the level of aminotransaminases. Ultrasound reveals hyperechoic tissue of the liver due to diffuse fatty infiltration. The degree of steatosis can also be estimated by a controlled attenuation parameter (CAP - Controlled Attenuation Parameter) in the fibroelastometry of liver tissue. It is also possible to verify the degree of fibrosis of liver tissue in its presence. Given that the mare's milk has therapeutic and dietary properties for various diseases of the internal organs, including liver diseases, the investigators decided to study its therapeutic effectiveness in NASH. In this clinical study, the effectiveness of mare's milk in NASH will be studied in comparison with control groups taking monotherapy with ursodeoxycholic acid (UDCA) and combined therapy (mare's milk and UDCA). Patients will receive a sublimated form of mare's milk in the appropriate dosage within 2 months, and the results of clinical laboratory and instrumental studies will be compared among themselves using statistical methods.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Supplement obtained through sublimation of mare milk, packed into one-dosage sachet (20g), and dissolved in a warm water (36 degrees of Celcius).
Ursodeoxycholic acid in the form of 250 mg capsule.
Medical Centre Hospital of the President's Affairs Administration
Astana, Kazakhstan
Change in liver function indicators
Blood samples will be taken to determine changes in bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase AST, gamma-glutamyl transpeptidase (GGTP), alkaline phosphatase,
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
Change in degree of steatosis and fibrosis (fibroelastometry method).
Degree of steatosis and fibrosis will evaluated via fibroelastometry method.
Time frame: Baseline, Week 8
Change in degree of steatosis and fibrosis (ultrasound method)
Ultrasound will be used for assessment of steatosis and fibrosis.
Time frame: Baseline, Week 8
Change in biochemical blood test results (cholesterol, glucose)
Proportion of those with deviations from normal range will be reported and compared across periods and groups.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
Change in weight.
Frequency of patients with decreased weight will be detected and compared across groups/periods.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
Detection of general clinical symptoms of non-alcoholic steatohepatitis.
Symptoms such as of malaise, abdominal discomfort, vague right upper quadrant abdominal pain will be identified in patients during physical examination.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
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