NCT03665519

Clinical Trial on the Effect of the Sublimated Mare Milk Supplement on Primary Biliary Cholangitis

Clinical Trial on the Effect of Sublimated Mare Milk Supplement in Patients With Biliary Cholangitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: National Scientific Medical Center, Kazakhstan · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the effect of sublimated mare milk supplement on patients with biliary cholangitis

Detailed description

Primary biliary cholangitis, formerly known as primary biliary cirrhosis, is a rare chronic disease that primarily affects women. Primary biliary cholangitis often progresses to the terminal stage of liver cirrhosis with its inherent complications. At this stage, the only way to save the patient's life is liver transplantation, and is accompanied by a number of painful symptoms (itching, mucous dryness, abdominal discomfort, fatigue), often restless legs syndrome, insomnia, depression and cognitive dysfunction. The goal of the treatment is to prevent the terminal stage of cirrhosis of the liver and to alleviate the accompanying symptoms. Conventional drug therapy is aimed at slowing the progression of the disease and includes both approved for the use of these medications (ursodeoxycholic acid) and used outside the approved indications (derivatives of fibric acid, budesonide). The role of this clinical trial is to increase the effectiveness of therapy for this disease. Against the background of the complexity of the treatment of primary biliary cholangitis, clinical medicine acquires a remedy in the form of a natural product - mare's milk, preventive, dietary, medicinal effects of which have been known for a long time. There are data from studies that have shown the efficacy and safety of using mare milk in patients with atopic dermatitis as well as with inflammatory bowel diseases. For the liver diseases, there are no reported studies. In this trial, there will be two parallel groups: Interventional (supplement with standard treatment first for 3 months) and Standard treatment group. Differences in clinical, laboratory, liver encephalopathy and asthenia will be evaluated between groups.

Conditions

• Primary Biliary Cirrhosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Sublimated mare milk	The dietary supplement mare milk product, which is obtained from fresh mare milk (few hours) through sublimation process.
DRUG	Ursodeoxycholic Acid	Ursodeoxycholic acid treatment will be given for 3 months.

Timeline

• Start date: 2018-01-03
• Primary completion: 2020-09-01
• Completion: 2020-12-01
• First posted: 2018-09-11
• Last updated: 2021-01-26

Locations

1 site across 1 country: Kazakhstan