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

Effect of Chazhu Xiaozhi Decoction on Non-alcoholic Fatty Liver Disease: a Randomized Clinical Trial

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 Overview

• Status: Completed
• Conditions: Hepatic Steatosis; Symptoms and Signs
• Intervention / Treatment: Drug: Chazhu Xiaozhi decoction; Drug: Control placebo

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200071
      • Shanghai Municipal Hospital of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	through study completion, an average of 8 weeks
traditional Chinese medicine syndrome scale	The traditional Chinese medicine syndrome scale includes evaluations of symptoms such as discomfort in the right flank, bloating in the epigastric region, bitter mouth, dry mouth, loose and loose stools, fatigue and fatigue throughout the body, loss of appetite, nausea, dizziness, and yellow urine, with a score range from 0 to 3, and higher scores mean a worse outcome.	through study completion, an average of 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body weight	weighing on a scale	through study completion, an average of 8 weeks
body mass index	calculate	through study completion, an average of 8 weeks
fasting blood glucose	serum biochemistry	through study completion, an average of 8 weeks
alanine aminotransferase	serum biochemistry	through study completion, an average of 8 weeks
aspartate transaminase	serum biochemistry	through study completion, an average of 8 weeks
γ-glutamyl transpeptidase	serum biochemistry	through study completion, an average of 8 weeks
triglyceride	serum biochemistry	through study completion, an average of 8 weeks
total cholesterol	serum biochemistry	through study completion, an average of 8 weeks
creatinine	serum biochemistry	through study completion, an average of 8 weeks
urea nitrogen	serum biochemistry	through study completion, an average of 8 weeks

Collaborators and Investigators

• Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2024
• Primary Completion (Actual): November 7, 2024
• Study Completion (Actual): January 2, 2025

Study Registration Dates

• First Submitted: May 23, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): June 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 29, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: CXD20240523; 20234Y0142 (Other Grant/Funding Number: Shanghai Municipal Health Commission)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No