Nonalcoholic Fatty Liver Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRI PDFF; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fibro Touch (CAP);liver function;blood fat;Uric Acid;B-scan ultrasonography;scores of TCM syndrome;weight;waist; | — |
Countries
China
Contacts
Institute of Liver Disease, Shuguang Hospital affiliated with Shanghai University of TCM