Non-alcoholic Fatty Liver Disease
Conditions
Interventions
Hugan Decoction combined with Bicyclol Tablets treatment group:On the basis of oral administration of Bicyclol, patients orally take Hugan Decoction, one dose per day, taken 30 minutes after meals, wi
Bicyclol Tablets treatment group:Bicyclol (25 mg/tablet), 2 tablets per dose, 3 times daily, taken before meals, with a treatment course of 24 weeks.
Sponsors
Tianjin Integrated Traditional Chinese and Western Medicine Hospital (Tianjin Nankai Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Patients meeting the diagnostic criteria. (2) Serum ALT level exceeding 1.5 times the upper limit of normal (ULN). (3) Total bilirubin level less than 3 times the upper limit of normal (ULN). (4) Agreement to the treatment plan and signing of the informed consent form. (5) Age between 18 and 65 years old.
Exclusion criteria
Exclusion criteria: (1) Patients who do not meet the diagnostic criteria. (2) Patients comorbid with other liver diseases, such as alcoholic liver disease (weekly ethanol intake =210 g for males, =140 g for females), viral hepatitis, autoimmune liver disease, malignant liver tumor, drug-induced liver injury, decompensated cirrhosis, etc. (3) Patients who have taken Chinese or Western medicines or health supplements capable of causing transaminase elevation within the past 3 months are excluded from enrollment. (4) Patients with severe comorbid diseases affecting drug metabolism, such as cardiovascular and cerebrovascular diseases, kidney diseases, infectious diseases, etc. (5) Pregnant or lactating women. (6) Patients with a history of severe allergies. (7) Patients with poor compliance who are unable to cooperate in completing the study. (8) Patients with other conditions deemed unsuitable for enrollment by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| alanine aminotransferase, ALT;TCM syndrome score; | — |
Secondary
| Measure | Time frame |
|---|---|
| red blood cell count;hemoglobin;white blood cell count;platelet count;aspartate aminotransferase, AST;total bilirubin, TBil;direct bilirubin, DBiL;alkaline phosphatase, ALP;total bile acid, TBA;albumin, ALB;?-glutamyl transpeptidase, GGT;PT;total cholesterol, TC;triglyceride, TG;low-density lipoprotein cholesterol, LDL-C;high-density lipoprotein cholesterol, HDL-C;remnant cholesterol, RC;apolipoprotein A1, Apo A1;fasting blood glucose, FBG;fasting insulin, FINS;glycated hemoglobin A1c, HbA1c;controlled attenuation parameter, CAP;liver stiffness measurement, LSM;height;body weight, BW;body temperature, T;heart rate, HR;blood pressure, BP;waist circumference, WC; | — |
Countries
China
Contacts
Public ContactMing Chen
Tianjin Integrated Traditional Chinese and Western Medicine Hospital (Tianjin Nankai Hospital)
Outcome results
None listed