A Clinical Trial of Chazhu Xiaozhi Decoction Against Non-alcoholic Fatty Liver Disease

Más betegség

• 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.);
• Has other serious liver diseases, such as autoimmune liver diseases, primary biliary cholangitis, Wilson's disease, etc.;
• Has other serious systemic diseases, such as malignant tumors, active systemic lupus erythematosus, etc.;
• Known allergy or intolerance to any component of the study medication;
• Has severe mental illness or behavioral disorders that may affect adherence to the study protocol;
• Other conditions that the researcher considers unsuitable for participation in this study.

Laborértékek

• 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.;

Életkor

• Pregnant women, lactating women, or women of childbearing age who refuse to use effective contraception during the trial;

Egyéb

• Has participated in another clinical trial within the last three months;

• According to the diagnostic criteria, patients with NAFLD and Spleen Deficiency and Damp-Heat Syndrome are selected. The specific criteria are as follows:
• Age 18-50 years, both genders eligible;
• Meets the diagnostic criteria for NAFLD;
• Meets the diagnostic criteria for Traditional Chinese Medicine Spleen Deficiency and Damp-Heat Syndrome;
• Has significant risk factors: CAP≥238dB/m, Body Mass Index (BMI) ≥23 kg/m²;
• Has not received any anti-NAFLD medication treatment in the past month;
• 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;
• Has sufficient cognitive and understanding abilities to comprehend the study content and its potential risks and benefits;
• Voluntarily participates in the study and signs an informed consent form.