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

NCT ID: NCT06442137

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-17
• Study Completion Date: 2025-01-02

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

Conditions

Hepatic Steatosis; Symptoms and Signs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment group

These medicines of Chazhu Xiaozhi decoction are uniformly decocted, prepared, and packaged by the Pharmacy of Shanghai Municipal Hospital of Traditional Chinese Medicine. The administration is oral, taken twice daily, one packet each time, for a treatment period of 8 weeks.

In addition, following the guidelines, all participants will receive lifestyle interventions, including diet and exercise health education before enrollment to ensure calorie control and exercise compliance.

Group Type: EXPERIMENTAL

Chazhu Xiaozhi decoction

Intervention Type: DRUG

Below is the composition of Chazhu Xiaozhi decoction: Camellia Sinensis Radix 15g, Atractylodis Rhizoma 15g, Herba Gynostemmatis Pentaphylli 15g, Ilicis Cornutae Folium 15g, Alismatis Rhizoma 9g, Nelumbinis Folium 6g, Crataegi Fructus 6g, Polygoni Orientalis Fructus 3g.

Control group

These placebo medicines are uniformly decocted, prepared, and packaged by the Pharmacy of Shanghai Municipal Hospital of Traditional Chinese Medicine. The administration is oral, taken twice daily, one packet each time, for a treatment period of 8 weeks.

In addition, following the guidelines, all participants will receive lifestyle interventions, including diet and exercise health education before enrollment to ensure calorie control and exercise compliance.

Group Type: PLACEBO_COMPARATOR

Control placebo

Intervention Type: DRUG

The control placebo is a ten-fold dilution of the Chazhu Xiaozhi decoction, supplemented with colorants and bittering agents to mimic the appearance and color of the treatment drug.

Interventions

Chazhu Xiaozhi decoction

Below is the composition of Chazhu Xiaozhi decoction: Camellia Sinensis Radix 15g, Atractylodis Rhizoma 15g, Herba Gynostemmatis Pentaphylli 15g, Ilicis Cornutae Folium 15g, Alismatis Rhizoma 9g, Nelumbinis Folium 6g, Crataegi Fructus 6g, Polygoni Orientalis Fructus 3g.

Intervention Type: DRUG

Control placebo

The control placebo is a ten-fold dilution of the Chazhu Xiaozhi decoction, supplemented with colorants and bittering agents to mimic the appearance and color of the treatment drug.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Municipal Hospital of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

20234Y0142

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CXD20240523

Identifier Type: -

Identifier Source: org_study_id