non-alcoholic fatty liver disease
Conditions
Interventions
Treatment group:Chazhu Xiaozhi decoction
Control group:Comparison simulation decoction
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: According to the diagnostic criteria, patients with NAFLD and Spleen Deficiency and Damp-Heat Syndrome are selected. The specific criteria are as follows: (1) Age 18-50 years, both genders eligible; (2) Meets the diagnostic criteria for NAFLD; (3) Meets the diagnostic criteria for Traditional Chinese Medicine Spleen Deficiency and Damp-Heat Syndrome; (4) Has significant risk factors: CAP=238dB/m, Body Mass Index (BMI) =23 kg/m², Triglycerides =1.7 mmol/L; (5) Has not received any anti-NAFLD medication treatment in the past month; (6) Normal major organ function, including heart, kidney, and liver functions, specifically: no significant abnormalities on electrocardiogram; normal serum creatinine and urea nitrogen; normal serum bilirubin and albumin levels; (7) Has sufficient cognitive and understanding abilities to comprehend the study content and its potential risks and benefits; (8) Voluntarily participates in the study and signs an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Has liver steatosis due to other definitive causes, such as alcoholic liver disease, drug-induced liver injury, viral hepatitis infections (e.g., hepatitis B, hepatitis C, etc.); (2) Has other serious liver diseases, such as autoimmune liver diseases, primary biliary cholangitis, Wilson's disease, etc.; (3) Has severe dysfunction of major organs such as the heart, kidneys, lungs, etc., such as severe heart failure (NYHA functional classification III or above), renal failure (glomerular filtration rate eGFR < 30 mL/min/1.73m²), acute exacerbation of chronic obstructive pulmonary disease, etc.; (4) Has other serious systemic diseases, such as malignant tumors, active systemic lupus erythematosus, etc.; (5) Known allergy or intolerance to any component of the study medication; (6) Has participated in another clinical trial within the last three months; (7) Pregnant women, lactating women, or women of childbearing age who refuse to use effective contraception during the trial; (8) Has severe mental illness or behavioral disorders that may affect adherence to the study protocol; (9) Other conditions that the researcher considers unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| controlled attenuation parameter;traditional Chinese medicine syndrome scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| body weight;body mass index;fasting blood glucose;alanine aminotransferase;aspartate transaminase;?-glutamyl transpeptidase;triglyceride;total cholesterol; | — |
Countries
China
Contacts
Public ContactZheng Yiyuan
Shanghai Municipal Hospital of Traditional Chinese Medicine
Outcome results
None listed