The Sublimated Mare Milk Supplement In Patients With Hepatitis C
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in liver function.
研究概览
简要总结
This clinical trial studies the effect of sublimated mare milk supplement on patients with hepatitis C.
详细描述
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.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Dietary supplement and standard therapy.
Participants will take a supplement of 1 sachet (20 mg) 3 times/day accompanied with the standard therapy for 1 month.
干预措施: Mare milk supplement (Dietary Supplement)
Dietary supplement and standard therapy.
Participants will take a supplement of 1 sachet (20 mg) 3 times/day accompanied with the standard therapy for 1 month.
干预措施: Standard therapy (Drug)
Standard therapy only.
Patients would be given standard treatment for 1 month.
干预措施: Standard therapy (Drug)
结局指标
主要结局
Change in liver function.
时间窗: Baseline, 2 weeks, 4 weeks, 8 weeks
Change in liver function will be assessed from biochemical blood results of alanine transaminase and aspartate transaminase.
Change in urine test.
时间窗: Baseline, 2 weeks, 4 weeks, 8 weeks
Proportion of patients with deviations from normal range of urine test.
次要结局
- Changes in gut microbiota composition.(Baseline, 2 weeks, 4 weeks, 8 weeks)
- Changes in degree of liver fibrosis.(Baseline, 2 weeks, 4 weeks, 8 weeks)
- Intestinal immune status changes.(Baseline, 2 weeks, 4 weeks, 8 weeks)
- Changes in phospholipids spectrum of lymphocyte membranes.(Baseline, 2 weeks, 4 weeks, 8 weeks)
研究者
Yermekbayeva Bakytgul
Principal Investigator, MD, PhD
Asfendiyarov Kazakh National Medical University