The Metabolic Effects of Ginseng Oligopeptide Preparation on Non- Alcoholic Fatty Liver Disease With Obesity: a Randomized Controlled Double-blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- aspartate aminotransferase (AST)
研究概览
简要总结
To investigate the effect of ginseng oligopeptide on nonalcoholic fatty liver disease with obesity and clarify its intervention mechanism in theory, which will contribute to the prevention and treatment of non-alcoholic fatty liver more scientifically and effectively.The patients were randomly divided into two groups. One group of patients took ginseng oligopeptide orally, and the other group took placebo. The liver function, blood lipid, blood glucose, liver B ultrasound and other indicators were observed to further determine the efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Meet the diagnostic criteria for non-alcoholic fatty liver disease ;
- •Aged 18-65 years old;
- •ALT, AST, GGT≤2×Upper Limit Of Normal（ULN）;
- •BMI≥28Kg/㎡;
- •Patients signed the relevant informed consent on a voluntary basis.
排除标准
- •Under 18 years old and over 65 years old;
- •Allergic to the ingredients of ginseng oligopeptide preparation;
- •Serum ALT, AST, GGT>2ULN;
- •Currently taking oral hepatoprotective drugs such as reduced glutathione, polyene phosphatidylcholine, and silibinin, etc.;
- •Subjects participating in other clinical trials;
- •Pregnant or lactating women;
- •Complicated with serious diseases of the digestive system or other systems, such as chronic gastrointestinal diseases and chronic diseases causing digestive malabsorption,Kidney disease, hematological system or autoimmune diseases;
- •Other populations that were deemed by the investigators to be ineligible for the trial may reduce or complicate enrollment patients with chemotherapy.
结局指标
主要结局
aspartate aminotransferase (AST)
时间窗: The day of enrollment, day 60 and day 120 after enrollment.
Liver function
Alanine aminotransferase (ALT)
时间窗: The day of enrollment, day 60 and day 120 after enrollment.
Liver function
glutamyltransferase (GGT).
时间窗: The day of enrollment, day 60 and day 120 after enrollment.
Liver function
次要结局
未报告次要终点