Clinical trial NCT06848907: Clinical Study on the Treatment of MAFLD With Ganzhixiao Capsules
Official title: Re Evaluation of the Clinical Efficacy of Ganzhixiao Capsules Based on MRI-PDFF in the Treatment of Metabolic Related Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: MAFLD
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: MRI-PDFF
timeFrame: 16 weeks
Secondary outcomes:
measure: ALT
timeFrame: 16 weeks
measure: CK18
timeFrame: 16 weeks
measure: FIB-4
timeFrame: 16 weeks
measure: LSM
timeFrame: 16 weeks
measure: body weight
timeFrame: 16 weeks
measure: waist circumference
timeFrame: 16 weeks
measure: hip circumference
timeFrame: 16 weeks
measure: waist to hip ratio
timeFrame: 16 weeks
measure: Waist hip height ratio
timeFrame: 16 weeks
measure: Self-Rating Anxiety Scale
timeFrame: 16 weeks
measure: Self-rating depression scale
timeFrame: 16 weeks
measure: Pittsburgh sleep quality index
timeFrame: 16 weeks
measure: Damp Heat Traditional Chinese Medicine Syndrome Scale
timeFrame: 16 weeks
Other outcomes:
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