Evaluation Of The Therapeutic And Dietary Properties Of The Sublimated Mare's Milk Supplement In Patients With Non-Alcoholic Steatohepatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in degree of steatosis and fibrosis (fibroelastometry method).
研究概览
简要总结
This study evaluates the dietary and therapeutic effect of supplement consisting of sublimated mare milk among patients with non-alcoholic steatohepatitis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Dietary supplement only
Participants will take a sublimated mare milk of 1 sachet 3 times a day during 2 months.
干预措施: Sublimated mare's milk (Dietary Supplement)
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.
干预措施: Sublimated mare's milk (Dietary Supplement)
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.
干预措施: Ursodeoxycholic Acid (Drug)
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.
干预措施: Ursodeoxycholic Acid (Drug)
结局指标
主要结局
Change in degree of steatosis and fibrosis (fibroelastometry method).
时间窗: Baseline, Week 8
Degree of steatosis and fibrosis will evaluated via fibroelastometry method.
Change in degree of steatosis and fibrosis (ultrasound method)
时间窗: Baseline, Week 8
Ultrasound will be used for assessment of steatosis and fibrosis.
Change in liver function indicators
时间窗: 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,
次要结局
- Change in weight.(Baseline, Week 2, Week 4, Week 6, Week 8)
- Change in biochemical blood test results (cholesterol, glucose)(Baseline, Week 2, Week 4, Week 6, Week 8)
- Detection of general clinical symptoms of non-alcoholic steatohepatitis.(Baseline, Week 2, Week 4, Week 6, Week 8)