Clinical trial NCT06442137: A Clinical Trial of Chazhu Xiaozhi Decoction Against Non-alcoholic Fatty Liver Disease
Official title: Effect of Chazhu Xiaozhi Decoction on Non-alcoholic Fatty Liver Disease: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatic Steatosis
Symptoms and Signs
Lead sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups in parallel for the duration of the study
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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;
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.

Primary outcomes:
measure: controlled attenuation parameter
timeFrame: through study completion, an average of 8 weeks
measure: traditional Chinese medicine syndrome scale
timeFrame: through study completion, an average of 8 weeks
Secondary outcomes:
measure: body weight
timeFrame: through study completion, an average of 8 weeks
measure: body mass index
timeFrame: through study completion, an average of 8 weeks
measure: fasting blood glucose
timeFrame: through study completion, an average of 8 weeks
measure: alanine aminotransferase
timeFrame: through study completion, an average of 8 weeks
measure: aspartate transaminase
timeFrame: through study completion, an average of 8 weeks
measure: γ-glutamyl transpeptidase
timeFrame: through study completion, an average of 8 weeks
measure: triglyceride
timeFrame: through study completion, an average of 8 weeks
measure: total cholesterol
timeFrame: through study completion, an average of 8 weeks
measure: creatinine
timeFrame: through study completion, an average of 8 weeks
measure: urea nitrogen
timeFrame: through study completion, an average of 8 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Municipal Hospital of Traditional Chinese Medicine
state: Shanghai
Study officials:
References: