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NCT06848907Not yet recruitingPhase 2

Clinical Study on the Treatment of MAFLD With Ganzhixiao Capsules

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

Source: ClinicalTrials.gov · Last updated 11 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
138 (estimated)
First submitted
15 Feb 2025
Start date
30 May 2025
Primary completion date
30 May 2028
Lead sponsor
Dong Hui
NCT number
NCT06848907

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 138
  • From 30 May 2025 to the primary completion date, 30 May 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Taking some hypoglycemic, lipid-lowering, liver protective drugs or high-dose vitamin E that may affect the efficacy judgment in the past three months;
  • Those who require long-term hormone therapy;
  • 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.

Other illness

  • Alcoholic fatty liver, other chronic liver diseases, cirrhosis, liver malignant tumors, etc.;
  • Type 2 diabetes and pancreatic diseases;
  • Patients with severe infections, cardiovascular, respiratory, renal, hematological, rheumatic connective tissue disease, neuropsychiatric, and non liver malignant tumors;

Lab values

  • 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;

Other

  • Pregnant or lactating women;
  • Researchers anticipate poor compliance or inability to cooperate;

Who the study is looking for

  • 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

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.