Therapeutic And Dietary Effects Of The Sublimated Mare's Milk Supplement In Patients With Non-Alcoholic Steatohepatitis

Medical Centre Hospital of the President's Affairs Administration, Republic of Kazakhstan

Status: Completed

Conditions: Non-alcoholic Steatohepatitis

Treatments: Dietary Supplement: Sublimated mare's milk; Drug: Ursodeoxycholic Acid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03664596

UDP.NAS.01

Details and patient eligibility

About

This study evaluates the dietary and therapeutic effect of supplement consisting of sublimated mare milk among patients with non-alcoholic steatohepatitis.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

Dietary supplement only

Experimental group

Description:

Participants will take a sublimated mare milk of 1 sachet 3 times a day during 2 months.

Treatment:

Dietary Supplement: Sublimated mare's milk

Dietary supplement and ursodeoxycholic acid therapy

Other group

Description:

Patients with non-alcoholic steatohepatitis will take ursodeoxycholic acid (2-3 times/day) combined with the mare's milk supplement (1 sachet, 3 times/day) for two months.

Treatment:

Dietary Supplement: Sublimated mare's milk

Drug: Ursodeoxycholic Acid

Ursodeoxycholic acid therapy only

Active Comparator group

Description:

Patients with verified diagnosis of non-alcoholic steatohepatitis would be given treatment of ursodeoxycholic acid (2-3 times/day) for a two-month period.

Treatment:

Drug: Ursodeoxycholic Acid