NCT03664596

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Medical Centre Hospital of the President's Affairs Administration, Republic of Kazakhstan · Other Government
• Sex: All
• Age: 16 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-alcoholic Steatohepatitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Sublimated 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).
DRUG	Ursodeoxycholic Acid	Ursodeoxycholic acid in the form of 250 mg capsule.

Timeline

• Start date: 2018-08-01
• Primary completion: 2020-09-01
• Completion: 2020-12-01
• First posted: 2018-09-10
• Last updated: 2021-02-05

Locations

1 site across 1 country: Kazakhstan