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

February 3, 2021 updated by: Medical Centre Hospital of the President's Affairs Administration, Republic of Kazakhstan

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
      • Astana, Kazakhstan, 010000
        • Medical Centre Hospital of the President's Affairs Administration

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 56 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dietary supplement only
Participants will take a sublimated mare milk of 1 sachet 3 times a day during 2 months.
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).
Other: Dietary supplement and ursodeoxycholic acid therapy
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.
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.
Active Comparator: Ursodeoxycholic acid therapy only
Patients with verified diagnosis of non-alcoholic steatohepatitis would be given treatment of ursodeoxycholic acid (2-3 times/day) for a two-month period.
Drug: Ursodeoxycholic Acid
Ursodeoxycholic acid in the form of 250 mg capsule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in liver function indicators
Time Frame: 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,
Baseline, Week 2, Week 4, Week 6, Week 8
Change in degree of steatosis and fibrosis (fibroelastometry method).
Time Frame: Baseline, Week 8
Degree of steatosis and fibrosis will evaluated via fibroelastometry method.
Baseline, Week 8
Change in degree of steatosis and fibrosis (ultrasound method)
Time Frame: Baseline, Week 8
Ultrasound will be used for assessment of steatosis and fibrosis.
Baseline, Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in biochemical blood test results (cholesterol, glucose)
Time Frame: 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.
Baseline, Week 2, Week 4, Week 6, Week 8
Change in weight.
Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8
Frequency of patients with decreased weight will be detected and compared across groups/periods.
Baseline, Week 2, Week 4, Week 6, Week 8
Detection of general clinical symptoms of non-alcoholic steatohepatitis.
Time Frame: 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.
Baseline, Week 2, Week 4, Week 6, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Eurasia Invest Ltd.
Ministry of Education and Science, Republic of Kazakhstan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

September 6, 2018

First Submitted That Met QC Criteria

September 7, 2018

First Posted (Actual)

September 10, 2018

Study Record Updates

Last Update Posted (Actual)

February 5, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDP.NAS.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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