Metabolism-related fatty liver disease
Conditions
Interventions
test group:The control group was treated with bear bile powder on the basis of 0.3g/times 2 times/d
control group:Refer to the Mediterranean diet guidance and exercise check-in control
Sponsors
Department of Hepatology Shuguang Hospital Shanghai University of Traditional Chinese Medicine China
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Meet the Chinese and Western medical diagnostic criteria for MAFLD Damp-Heat Embedded Stagnation Certificate [1]; 2) Between the ages of 18-65 years old with no gender limitation; 3) MRI-PDFF screening results suggestive of steatosis (=5%); 4) Serum ALT = 2 ULN; 5) No other medications for MAFLD in the last 4 weeks; 6) Able to voluntarily provide written signed and dated informed consent; 7) Able to understand and have the ability and willingness to fully comply with the procedures and limitations imposed by the study.
Exclusion criteria
Exclusion criteria: Compliance with one of the following was excluded. 1)other acute or chronic liver disease and excessive alcohol consumption (weekly ethanol intake = 210g for men and = 140g for women) 2) Patients with imaging and biochemical evidence of MASH metabolic-related steatohepatic fibrosis metabolic-related steatohepatic cirrhosis (or confirmed by hepatic puncture biopsy). 3)Patients with combined heart brain kidney haematopoietic system and other serious primary diseases 4) patients with acute gestational fatty liver lipid deposition disease focal fatty liver hepatic fatty tumour etc. 5) Patients with severe emotional and mental illnesses 6)women who are pregnant or preparing for pregnancy breastfeeding women 7)LSM = 8 Pa and FIB-4 score = 1.3 8)Unstable weight (>5% change in the previous 3 months) 9)Diabetic patients being treated with insulin or oral hypoglycaemic and lipid-lowering drugs 10)Current use of medications that may interfere with the action absorption or disposition of the study treatment or clinical studies (e.g. weight-loss medications) 11)Contraindications to MRI (pacemakers Klaus phobia implantation of medical devices with ferromagnetic properties) 12)Bear bile powder drug allergy patients 13)Those who cannot follow the treatment protocol strictly 14)Patients with previous or planned bariatric surgery during the study period; 15)Participation in an investigational new drug clinical study within 30 days prior to randomisation 16)any other condition that in the opinion of the investigator may impede compliance prevent completion of the study harm the health of the subject or interfere with the study outcome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantification of liver fat PDFF; | — |
Secondary
| Measure | Time frame |
|---|---|
| Gamma-Glutamyl Transferase(GGT);Transaminase;controlled attenuation parameter,CAP;Liver Stiffness Measurement;Body mass index (BMI);Blood fat;Inbody;Waist-to-Hip Ratio, WHR;nonestesterified fatty acid NEFA;Blood Glucose;Serum Ferritin;Differentiation of syndromes; | — |
Countries
China
Contacts
Public ContactXuehua Sun
Shanghai Shuguang Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed