Clinical Study on the Treatment of MAFLD With Ganzhixiao Capsules

NCT06848907 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: TJ-IRB202504027
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

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.

Conditions

MAFLD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• ALT

  16 weeks

• CK18

  16 weeks

• FIB-4

  16 weeks

• LSM

  16 weeks

• body weight

  16 weeks

Study Arms (2)

Clinical study on the treatment of MAFLD with palcebo capsules

PLACEBO COMPARATOR

Drug: placebo capsule

Clinical study on the treatment of MAFLD with Ganzhixiao capsules

EXPERIMENTAL

Drug: ganzhixiao capsule

Interventions

ganzhixiao capsule 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.

Clinical study on the treatment of MAFLD with Ganzhixiao capsules

placebo capsule 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 palcebo capsules

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dong Hui: lead

Central Study Contacts

Zhi Wang

CONTACT

13487095852; 2410216693@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 27, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share