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

NCT06442137 | Completed Phase 2

• 2 other identifiers: CXD2024052320234Y0142
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• body weight

  through study completion, an average of 8 weeks

• body mass index

  through study completion, an average of 8 weeks

• fasting blood glucose

  through study completion, an average of 8 weeks

• alanine aminotransferase

  through study completion, an average of 8 weeks

• aspartate transaminase

  through study completion, an average of 8 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

Chazhu Xiaozhi decoction 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.

Treatment group

Control placebo 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.

Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.;
• 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 participated in another clinical trial within the last three months;
• Pregnant women, lactating women, or women of childbearing age who refuse to use effective contraception during the trial;
• 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.

Sponsors & Collaborators

• Shanghai Municipal Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Shanghai Municipal Hospital of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200071, China

Location

MeSH Terms

Conditions

Fatty Liver; Signs and Symptoms

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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. An independent researcher (not involved in the trial operations or evaluations) is responsible for managing the randomization sequence and drug coding, and will distribute the appropriate drugs to participants at the right times. This ensures that the trial operators and evaluators are unaware of the treatment type; only the independent researcher has this knowledge. During the experiment, the assessment of treatment effects and the recording of adverse events are carried out by independent evaluators who are unaware of the treatment groups. Both the trial operators and the evaluators do not have access to the drug coding and randomization sequence.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of two groups in parallel for the duration of the study

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 4, 2024
• Study Start: July 17, 2024
• Primary Completion: November 7, 2024
• Study Completion: January 2, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

CN (1)