The Sublimated Mare Milk Supplement in Hepatitis C

Asfendiyarov Kazakh National Medical University

Status: Completed

Conditions: Hepatitis C

Treatments: Drug: Standard therapy; Dietary Supplement: Mare milk supplement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03669835

KazNMU.MM.HC

Details and patient eligibility

About

This clinical trial studies the effect of sublimated mare milk supplement on patients with hepatitis C.

Full description

Chronic viral hepatitis C is one of the medical, social and economic public health problems throughout the world. In majority of patients with chronic viral hepatitis C, dysbiotic changes are detected in the intestinal tract. Disturbances of microbial equilibrium are associated with the degree of inflammation, morphological changes in the liver, nature of the course and the stage of the disease.

These dysbiotic changes and and associated immune disorders can significantly aggravate the course of immune processes in the liver, converting hepatitis C infection to a chronic disease.

Mare milk is frequently reported for having therapeutic and dietary properties, which are initially associated with a specific chemical composition and certain physical properties of the product. It contains a total of about 40 biologically active components, the most important of them vitamins A, C, B1, B2, B6, B12, amino acids, enzymes and trace elements, there are low molecular weight peptides, lactalbumins and globulins.

The use of mare milk can contribute to the restoration of impaired functions of damaged organs and tissues, and play the role of an auxiliary pathogenetic therapy, primarily in certain chronic diseases of the digestive system, including chronic viral hepatitis C. Mare milk can also be used as a powder supplement through sublimation process.

In this trial, the effect of this supplement consisting of sublimated mare milk on hepatitis C patients will be evaluated. There will be two parallel groups: Interventional (sublimated mare milk supplement with standard treatment) and Standard treatment group. Differences in laboratory characteristics will be quantitively analyzed between groups.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with verified diagnosis of hepatitis C
• Aged 18 to 65 years
• Normal intestinal microbiota composition (anaerobes-95%, aerobes-5%)
• Normal level of immune system markers in blood (Immunoglobulin M and Immunoglobulin G)
• Decreased levels of phosphatidylethanolamine, phosphatidylserine, phosphatidylcholine, sphingomyelin
• Elevated lysophosphatidylcholine
• Willingness to consent to participate in the study
• Consent to adhere to treatment

Exclusion criteria

• Drug and/or alcohol dependence
• Allergy to dairy products
• People with mental disabilities and/or life-threatening conditions
• Pregnancy and/or lactation
• Lactose intolerance
• 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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100 participants in 2 patient groups

Dietary supplement and standard therapy.

Experimental group

Description:

Participants will take a supplement of 1 sachet (20 mg) 3 times/day accompanied with the standard therapy for 1 month.

Treatment:

Drug: Standard therapy

Dietary Supplement: Mare milk supplement

Standard therapy only.

Other group

Description:

Patients would be given standard treatment for 1 month.

Treatment:

Drug: Standard therapy