Clinical Study on the Treatment of MAFLD With Ganzhixiao Capsules
ConditionMAFLD
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorDong Hui
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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;
Trial design
Treatments tested in this trial
- ganzhixiao capsule
- placebo capsule
Treatment groups
138 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Dong Hui
Lead sponsor
Tongji Hospital
Sponsor institution
Source ClinicalTrials.gov