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

Shanghai Municipal Hospital of Traditional Chinese Medicine70 enrolled

Overview

The goal of this clinical trial is to learn if drug Chazhu Xiaozhi decoction works to treat non-alcoholic fatty liver disease in adults. It will also learn about the safety of drug Chazhu Xiaozhi decoction. The main questions it aims to answer are: Does drug Chazhu Xiaozhi decoction improve the degree of hepatic steatosis in patients with non-alcoholic fatty liver disease? What medical problems do participants have when taking drug Chazhu Xiaozhi decoction? Researchers will compare drug Chazhu Xiaozhi decoction to a placebo (a look-alike substance that contains no drug) to see if drug Chazhu Xiaozhi decoction works to treat non-alcoholic fatty liver disease. Participants will: Take drug Chazhu Xiaozhi decoction or a placebo every day for eight weeks Keep a record of their symptoms and the degree of hepatic steatosis before and after the treatment

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hepatic Steatosis Symptoms and Signs

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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; 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: 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.

Outcomes

Primary Outcomes

controlled attenuation parameter

A liver fiber diagnostic instrument (Fibro Touch) is used to perform instantaneous elastic hardness testing. The controlled attenuation parameter usually represents liver fat content, whereas higher scores mean a worse outcome.