Clinical Study on the Treatment of MAFLD With Ganzhixiao Capsules

Re Evaluation of the Clinical Efficacy of Ganzhixiao Capsules Based on MRI-PDFF in the Treatment of Metabolic Related Fatty Liver Disease

This trial is expected to enroll 138 MAFLD patients in one clinical center, who will be randomly divided into a placebo group and a Ganzhixiao capsule group in a 1:1 ratio. There will be 69 patients in the Ganzhixiao group and 69 patients in the placebo group. Administer Ganzhixiao capsules or mimetics separately, intervene for 16 weeks, and compare the liver fat content、 ALT、 Changes in indicators such as cytokeratin 18 fragment, FIB-4 score, and LSM score. Among them, MRI-PDFF is the main efficacy evaluation index to evaluate the clinical efficacy of Ganzhixiao capsules in the treatment of MAFLD.

Study Overview

• Status: Not yet recruiting
• Conditions: MAFLD
• Intervention / Treatment: Drug: placebo capsule; Drug: ganzhixiao capsule

Detailed Description

All participants in the trial were required to have a low-fat diet and engage in aerobic exercise for 150 minutes per week.

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhi Wang; Phone Number: 13487095852; Email: 2410216693@qq.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age between 18 and 70 years old, with a body mass index (BMI) of at least 24kg/m2;
• Diagnosis of NAFLD determined by imaging [ultrasound, computed tomography or magnetic resonance imaging (MRI-PDFF)] or liver biopsy, showing MAFLD or simple steatosis within the last 24 months prior to screening;
• MAFLD patients conform to the damp heat syndrome type; ④ Voluntary signing of informed consent form

Exclusion Criteria:

• Blood biochemical indicators ALT, AST, BUN are greater than 1.5 times the upper limit of normal values, Cr is greater than the upper limit of normal values, eGFR<60ml/min/1.73m2;
• Alcoholic fatty liver, other chronic liver diseases, cirrhosis, liver malignant tumors, etc.;
• Type 2 diabetes and pancreatic diseases;
• Taking some hypoglycemic, lipid-lowering, liver protective drugs or high-dose vitamin E that may affect the efficacy judgment in the past three months;
• Patients with severe infections, cardiovascular, respiratory, renal, hematological, rheumatic connective tissue disease, neuropsychiatric, and non liver malignant tumors;
• Pregnant or lactating women;
• Those who require long-term hormone therapy;
• Researchers anticipate poor compliance or inability to cooperate;
• There are contraindications for MRI examination, including pacemakers or cochlear implants, postoperative artificial valve replacement, presence of ferromagnetic vascular clips in the body, metal foreign bodies in the eyeball, insulin pumps, ferromagnetic objects in the scanning field, metal dentures, intrauterine devices, and patients with claustrophobia.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Clinical study on the treatment of MAFLD with palcebo capsules	Drug: placebo capsule; Take 3 palcebo capsule each in the morning, afternoon, and evening, and swallow with warm water after meals for 16 weeks.All participants in the trial were required to have a low-fat diet and engage in aerobic exercise for 150 minutes per week.
Experimental: Clinical study on the treatment of MAFLD with Ganzhixiao capsules	Drug: ganzhixiao capsule; Ganzhixiao Capsule is mainly composed of Bupleurum chinense, Herba Artemisiae, Polygonum cuspidatum, Rhubarb and Hawthorn.Take 3 capsules each in the morning, afternoon, and evening, and swallow with warm water after meals for 16 weeks.All participants in the trial were required to have a low-fat diet and engage in aerobic exercise for 150 minutes per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI-PDFF	MRI PDFF (Magnetic Resonance Proton Density Fat Fraction) is a non-invasive magnetic resonance technique used to evaluate the fat content of the liver. It reflects the concentration of free TG in tissues by measuring the ratio of the proton density of free TG to the total proton density of free TG and water, expressed as a percentage (%).	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ALT	ALT (Alanine Aminotransferase) is an indicator that can reflect liver function damage，which is measured in blood .	16 weeks
CK18	Cell corner fragment 18 (CK18) is mainly used as a specific indicator for evaluating liver cell apoptosis, which can help us understand the degree and nature of liver damage. CK18 is measured in blood.	16 weeks
FIB-4	The Fibrosis 4 Score (FIB-4) is a non-invasive indicator for assessing the degree of liver fibrosis in patients with chronic liver disease. This scoring system calculates the degree of liver fibrosis using simple blood indicators, including age, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and platelet count (PLT).	16 weeks
LSM	The LSM score, also known as Liver Stiffness Measurement, is an indicator used to evaluate the degree of liver fibrosis through FibroScan.	16 weeks
body weight	body weight	16 weeks
waist circumference	waist circumference	16 weeks
hip circumference	hip circumference	16 weeks
waist to hip ratio	waist to hip ratio	16 weeks
Waist hip height ratio	Waist hip height ratio	16 weeks
Self-Rating Anxiety Scale	The Self Rating Anxiety Scale is used to assess an individual's anxiety symptoms	16 weeks
Self-rating depression scale	Self rating depression scale is used to assess an individual's depressive symptoms	16 weeks
Pittsburgh sleep quality index	Pittsburgh sleep quality index is used to evaluate an individual's sleep status	16 weeks
Damp Heat Traditional Chinese Medicine Syndrome Scale	Damp Heat Traditional Chinese Medicine Syndrome Scale is used to evaluate individual damp heat syndrome	16 weeks

Collaborators and Investigators

• Sponsor: Dong Hui

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2025
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2028

Study Registration Dates

• First Submitted: February 15, 2025
• First Submitted That Met QC Criteria: February 22, 2025
• First Posted (Actual): February 27, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: TJ-IRB202504027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No