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

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

Detailed Description
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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.

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

Conditions
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Non-alcoholic Steatohepatitis

Intervention / Treatment
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* Dietary Supplement: Sublimated mare's milk
* Drug: Ursodeoxycholic Acid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary supplement only<br>Participants will take a sublimated mare milk of 1 sachet 3 times a day during 2 months. | Dietary Supplement: Sublimated mare's milk<br>* Supplement obtained through sublimation of mare milk, packed into one-dosage sachet (20g), and dissolved in a warm water (36 degrees of Celcius).<br>|
| Other: Dietary supplement and ursodeoxycholic acid therapy<br>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<br>* Supplement obtained through sublimation of mare milk, packed into one-dosage sachet (20g), and dissolved in a warm water (36 degrees of Celcius).<br>Drug: Ursodeoxycholic Acid<br>* Ursodeoxycholic acid in the form of 250 mg capsule.<br>|
| Active Comparator: Ursodeoxycholic acid therapy only<br>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<br>* Ursodeoxycholic acid in the form of 250 mg capsule.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in liver function indicators | 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). | Degree of steatosis and fibrosis will evaluated via fibroelastometry method. | Baseline, Week 8 | 
| Change in degree of steatosis and fibrosis (ultrasound method) | 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) | 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. | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mare milk, Non-alcoholic Steatohepatitis, Immune markers