Clinical evaluation of Kuhuang Granules in the treatment of nonalcoholic steatohepatitis
- Conditions
- nonalcoholic steatohepatitis
- Registration Number
- ITMCTR2000003709
- Lead Sponsor
- Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Participate and sign the informed consent form voluntarily;
2. The age ranged from 18 to 60 years old;
3. According to the diagnosis of nonalcoholic steatohepatitis, the liver fat content was more than 5%, ALT <= 5 x ULN and > 1 x ULN;
4. Those who have not used other drugs for the treatment of nonalcoholic steatohepatitis within 3 months.
1. Nash related cirrhosis;
2. LDL > 4.14 mmol/L (indication for statins) or TG>5.6mmol/L (indication for fibrates);
3. Those who are using heparin, thyroxine and other drugs that affect fat metabolism;
4. Serious primary cardiovascular, liver, kidney, lung and hematological diseases, or serious diseases affecting survival, such as tumor or AIDS;
5. Pregnant and lactating women;
6. Those who have mental disorders can not give full informed consent;
7. People with allergic constitution or known to be allergic to the components of the drug;
8. Patients receiving other trial drugs within 3 months.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method liver CAP value;Analysis of liver fat content by magnetic resonance imaging;liver function (ALT, AST, AKP, GGT);
- Secondary Outcome Measures
Name Time Method waist-hip ratio;NAFLD liver fibrosis score;blood lipids;Body Mass Index;blood sugar;Insulin resistance index;CK18 level;weight;APRI;