Study for effect of Danggui Shaoyao Powder in the treatment of Non-alcoholic Fatty Liver Disease
- Conditions
- onalcoholic fatty liver disease
- Registration Number
- ITMCTR2000003921
- Lead Sponsor
- Shuguang Hospital affiliated to Shanghai University of TCM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Meet the diagnostic standard of the nonalcoholic fatty liver disease;
2. Aged 18-65 years old;
3. MRI-PDFF is greater than or equal to 10%;
4. ALT is greater than the upper limit of normal, and less than or equal to 5 times the upper limit of normal;
5. Signed informed consent.
1. Those who have used other liver-protecting and enzyme-lowering drugs which might affect the efficacy evaluation in the past 3 months;
2. Patients with alcoholic fatty liver (male alcohol intake> 20g / d, female alcohol intake> 10g / d);Patients with cirrhosis, HBV, HCV and other liver diseases; Patients with autoimmune liver disease; People who are taking any drug which might cause fatty liver;
3. Those with normal liver function;
4. Those who have undergone gastrointestinal weight loss surgery in the past year or those who have lost weight by more than 10% after taking weight-loss drugs within the past 3 months;
5. Pregnant women, lactating women, patients with primary diseases such as cardiovascular, lung, kidney, hematopoietic system, and other major diseases such as malignant tumors.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MRI-PDFF;
- Secondary Outcome Measures
Name Time Method insulin resistance index;serum levels of LDL;fasting blood-glucose;serum activity of ALT;weight;CLDQ NAFLD;SF-36;BMI;waistline; liver stiffness measurements;serum levels of TG;fasting insulin;serum levels of TC;serum levels of HDL-C;