Non-alcoholic Steatohepatitis
Conditions
Keywords
Non-alcoholic Steatohepatitis, Mare milk, Immune markers
Brief summary
This study evaluates the dietary and therapeutic effect of supplement consisting of sublimated mare milk among patients with non-alcoholic steatohepatitis.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTSublimated mare's milk
Supplement obtained through sublimation of mare milk, packed into one-dosage sachet (20g), and dissolved in a warm water (36 degrees of Celcius).
DRUGUrsodeoxycholic Acid
Ursodeoxycholic acid in the form of 250 mg capsule.
Sponsors
Eurasia Invest Ltd.
Ministry of Education and Science, Republic of Kazakhstan
Medical Centre Hospital of the President's Affairs Administration, Republic of Kazakhstan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a verified diagnosis of non-alcoholic steatohepatitis; * Aged 16 to 60 years; * Absence of an allergic reaction to dairy products; * Willingness to consent to participate in the study. * Consent to adhere to treatment
Exclusion criteria
* Taking antibiotics, cytostatics and steroids during the last 3 months; * Taking alcohol hepatotoxic doses (no more than 30 g alcohol per day for men and not more than 20 g for women); * History of oncological diseases; * Presence of diabetes mellitus, decompensated forms of diseases, intestinal dyspepsia, hypertension (blood pressure 140/90 mm Hg and more at the time of the initial visit to the doctor), tuberculosis; * A positive result of screening for antibodies to viral hepatitis B, C and D, as well as HIV * Presence of concomitant diseases of the kidneys, liver, cardiovascular, respiratory and other body systems, oncological, mental health and decompensated endocrine diseases, tuberculosis, and HIV infection; * Pregnancy and/or lactation; * Patient involvement in other clinical trials within the last 3 months; * Refusal to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in liver function indicators | Baseline, Week 2, Week 4, Week 6, Week 8 | Blood samples will be taken to determine changes in bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase AST, gamma-glutamyl transpeptidase (GGTP), alkaline phosphatase, |
| Change in degree of steatosis and fibrosis (fibroelastometry method). | Baseline, Week 8 | Degree of steatosis and fibrosis will evaluated via fibroelastometry method. |
| Change in degree of steatosis and fibrosis (ultrasound method) | Baseline, Week 8 | Ultrasound will be used for assessment of steatosis and fibrosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in biochemical blood test results (cholesterol, glucose) | Baseline, Week 2, Week 4, Week 6, Week 8 | Proportion of those with deviations from normal range will be reported and compared across periods and groups. |
| Change in weight. | Baseline, Week 2, Week 4, Week 6, Week 8 | Frequency of patients with decreased weight will be detected and compared across groups/periods. |
| Detection of general clinical symptoms of non-alcoholic steatohepatitis. | Baseline, Week 2, Week 4, Week 6, Week 8 | Symptoms such as of malaise, abdominal discomfort, vague right upper quadrant abdominal pain will be identified in patients during physical examination. |
Countries
Kazakhstan
Outcome results
None listed