Therapeutic Effects of Compound Zhenzhu Tiaozhi Capsules in Nonalcoholic Fatty Liver disease-a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Fat attenuation index
研究概览
简要总结
This is a randomised clinical trial which aims to evaluate the efficacy of Compound Zhenzhu Tiaozhi capsules in the treatment of NAFLD and analyze the relationship between improvement in NAFLD parameters and changes in intestinal functions.
详细描述
This is a randomised clinical trial which aims to evaluate the efficacy of Compound Zhenzhu Tiaozhi capsules in the treatment of NAFLD and analyze the relationship between improvement in NAFLD parameters and changes in intestinal functions. In this study, the investigators will (1)evaluate the relationship between the function of intestinal mucosal barrier, SIBO, and NAFLD;(2)assess the effects of Compound Zhenzhu Tiaozhi capsules on intrahepatic fat content, hepatic noninvasive score, liver biochemical parameters, blood lipid, and insulin resistance. To evaluate the therapeutic effects of Compound Zhenzhu Tiaozhi capsules on the treatment of NAFLD, and determine whether the risk stratification of atherosclerotic cardiovascular disease (ASCVD) and quality of life (using the 36-Item Short Form Health Survey [SF-36]) can be improved in NAFLD patients with Compound Zhenzhu Tiaozhi capsules;(3) compare the therapeutic effects of Compound Zhenzhu Tiaozhi capsules with conventional medications in the treatment of NAFLD, and to compare their efficacies in improving the risk stratification of ASCVD and quality of life, as assessed by the SF-36; (4) analyze the relationship of Compound Zhenzhu Tiaozhi capsules in improving NAFLD and parameters related to the function of the intestinal mucosal barrier and SIBO.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of simple steatosis or NASH 18 to 75 years old serum alanine transaminase (ALT)≤2 times the upper limit of normal
排除标准
- •other chronic liver diseases serious complications in other organs malignant tumors
研究组 & 干预措施
TLC group
transform life custom (TLC) group
干预措施: TLC (Dietary Supplement)
TLC + metformin group
transform life custom (TLC) combined with 0.5g metformin, PO tid
干预措施: TLC (Dietary Supplement)
TLC + metformin group
transform life custom (TLC) combined with 0.5g metformin, PO tid
干预措施: metformin (Drug)
TLC + CZT capsules group
transform life custom (TLC) combined with 2.52 Compound Zhenzhu Tiaozhi capsules (four tablets), PO tid
干预措施: TLC (Dietary Supplement)
TLC + CZT capsules group
transform life custom (TLC) combined with 2.52 Compound Zhenzhu Tiaozhi capsules (four tablets), PO tid
干预措施: Compound Zhenzhu Tiaozhi capsule (Drug)
TLC + simvastatin group
transform life custom (TLC) combined with 20mg simvastatin, PO qn
干预措施: TLC (Dietary Supplement)
TLC + simvastatin group
transform life custom (TLC) combined with 20mg simvastatin, PO qn
干预措施: Simvastatin (Drug)
结局指标
主要结局
Fat attenuation index
时间窗: at 6 months following therapy
The fat attenuation index will be used to assess the therapeutic efficacy. A normal fat attenuation index is defined as \< 240 db/m, mild is 240-264 db/m, moderate is 265-294 db/m, and severity is \> 295 db/m.We will detect the fat attenuation index at 6 months following treatment. Effective: fat attenuation index is reduced by a level or more (example: moderate to mild). Invalid: fails to meet the effective standard.
次要结局
- Serum triglyceride(at 6 months following therapy)
- Serum cholesterol(at 6 months following therapy)
- Serum lipoproteins(at 6 months following therapy)
- Hydrogen/methane breath testing(at 6 months following therapy)
- Quality of life(at 6 months following therapy)
研究者
He Xingxiang
Director of the Hospital
The First Affiliated Hospital of Guangdong Pharmaceutical University