non-alcoholic fatty liver disease
Conditions
Interventions
control group:Lifestyle intervention, Vitamin E, capsules 300 mg
treatment group:Lifestyle intervention, Compound Embryonic Bovine Liver Extract Tablets, 2# tid, for 48 weeks
Sponsors
Hangzhou Sixth Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male and female patients age 18-70 years; 2. A clinical or histologic or radiographic diagnosis of NAFLD (criteria of Society of Hepatology, Chinese Medical Association, 2010.3); 3. Have a liver biopsy performed within 3 months of randomization demonstrating features consistent with NAFLD; 4. BMI 23 to 30 kg/m2; 5. Elevated ALT or AST < 10 times ULN, and (or) persistent GGT elevation over 24 weeks prior to entry into study; 6. Fasting glucose <7.8mmol/L or Hb1Ac <6.5%.7.Willingness to give written informed consent and willingness to participate in and comply with the study requirements.
Exclusion criteria
Exclusion criteria: 1. Hepatocellular carcinoma (HCC) or suspicion of HCC; 2. History of liver disease (chronic viral hepatitis, drug-induced liver disease, autoimmune hepatitis, primary biliary cirrhosis, Wilson's disease, hemochromatosis and a1-antitrypsin deficiency); 3. Decompensated liver disease with the following criteria: Albumin 1.5*ULN); 5. Significant systemic illnesses or infectious diseases, including malignancy, cerebrovascular disease, pulmonary disease with hypoxia, serious psychiatric disease, HIV infection, schistosomiasis, clonorchiasis, seizure disorder and virus co-infections; 6. Total Bilirubin > 34.2umol, TC >6.0mmol/L, TG >2.3mmol/L; 7. Patients wth gestation or or lactation, or females who expecting gestation during clinical trial. Evidence of drug or substance abuse; 8. History of drug allergy to Anfate. Any other conditions, which, in the opinion of the investigators would impede competence or compliance or possibility of hindering completion of the study. 9. Use of any liver protectant and anti-inflammatory Chinese and Western medicine, antihyperlipidemic agents, anti-diabetic drugs and weight loss medications; 10. Patients with history of severe psychiatric disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver Histology;Noninvasive Diagnostic Model; | — |
Secondary
| Measure | Time frame |
|---|---|
| Anthropometric variables (BMI, W/H);symptom;laboratory tests;clinical adverse event; | — |
Countries
China
Contacts
Public ContactJunping Shi
Outcome results
None listed