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Not yet recruiting NCT06848907

Clinical Study on the Treatment of MAFLD With Ganzhixiao Capsules

Phase II Interventional MAFLD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ganzhixiao capsule, placebo capsule.
Who it may be relevant to
Registry conditions: MAFLD. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • MRI-PDFF [Time frame: 16 weeks]
Secondary outcome measures (12)
  • ALT [Time frame: 16 weeks]
  • CK18 [Time frame: 16 weeks]
  • FIB-4 [Time frame: 16 weeks]
  • LSM [Time frame: 16 weeks]
  • body weight [Time frame: 16 weeks]
  • waist circumference [Time frame: 16 weeks]
  • hip circumference [Time frame: 16 weeks]
  • waist to hip ratio [Time frame: 16 weeks]
  • Waist hip height ratio [Time frame: 16 weeks]
  • Self-Rating Anxiety Scale [Time frame: 16 weeks]
  • Self-rating depression scale [Time frame: 16 weeks]
  • Pittsburgh sleep quality index [Time frame: 16 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06848907 · TJ-IRB202504027

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗