Clinical evaluation of Yinchenhao decoction in the treatment of Nonalcoholic Fatty Liver Disease (hepatobiliary dampness-heat syndrome): a randomized controlled trial.
- Conditions
- onalcoholic Fatty Liver Disease
- Registration Number
- ITMCTR2000003508
- Lead Sponsor
- Shuguang Hospital affiliated with Shanghai University of TCM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
Referring to the diagnostic criteria of NAFLD in the guidelines for the prevention and treatment of non-alcoholic fatty liver disease (2018 update), the diagnostic criteria of hepatobiliary dampness-heat syndrome established by the consensus opinion on the diagnosis and treatment of non-alcoholic fatty liver disease by integrated traditional Chinese and western medicine (2017) are as follows:
1. Between the ages of 18 years and 60 years (including), there is no limit on sex;
2. Patients who meet the diagnostic criteria of NAFLD,Liver imaging findings meet the diagnostic criteria of diffused fatty liver, and there is no other reason to explain and / or have metabolic syndrome related components in patients with unknown causes of serum ALT, / or AST, GGT continued to increase for more than half a year.
3. Meet the diagnostic criteria of liver and gallbladder dampness-heat syndrome of traditional Chinese medicine.
4. MRI PDFF mean >= 8%, Willing to accept regular physical and chemical examinations related to fatty liver;
5. I or my guardian agree to participate in the clinical trial control study and sign the informed consent form.
1. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) > 5*ULN, total bilirubin (TBIL) > 2*ULN;
2. Alcoholic fatty liver (male alcohol intake > 210g/week, female alcohol intake > 140g/week);
3. Combined with viral, autoimmune and other liver diseases, or taking drugs that may cause fatty liver;
4. Combined with diabetes (glycated hemoglobin >= 6.5%, or fasting blood glucose >= 7.0mol/L, or 2 hours postprandial blood glucose >= 11.1mmol/L), malignant tumors, connective tissue diseases and severe heart, liver, hematopoietic, and nervous system complications , Or clearly have other important diseases;
5. Pregnant or breastfeeding women, allergic physique, allergic to drugs, and patients with mental illness;
6. Patients who have undergone gastrointestinal bariatric surgery within the past year or who have taken weight-loss drugs within the past three months have lost >10%.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MRI PDFF;
- Secondary Outcome Measures
Name Time Method scores of TCM syndrome;waist;Uric Acid;blood fat;weight;B-scan ultrasonography;Fibro Touch (CAP);liver function;