Clinical Study on the Treatment of MAFLD With Ganzhixiao Capsules

NCT ID: NCT06848907

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-30
• Study Completion Date: 2028-05-30

Brief Summary

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.

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.

Conditions

MAFLD

Study Design

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

Study Groups

Clinical study on the treatment of MAFLD with palcebo capsules

Group Type: PLACEBO_COMPARATOR

placebo capsule

Intervention Type: DRUG

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.

Clinical study on the treatment of MAFLD with Ganzhixiao capsules

Group Type: EXPERIMENTAL

ganzhixiao capsule

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dong Hui

OTHER

Sponsor Role: lead

Responsible Party

Dong Hui

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Zhi Wang

Role: CONTACT

2410216693@qq.com

13487095852

Other Identifiers

TJ-IRB202504027

Identifier Type: -

Identifier Source: org_study_id