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NCT Number: NCT06848907

Clinical Study on the Treatment of MAFLD With Ganzhixiao Capsules

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

All participants in the trial were required to have a low-fat diet and engage in aerobic exercise for 150 minutes per week.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. MRI-PDFF

    Time frame: 16 weeks

    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 (%).

Secondary outcomes

  1. ALT

    Time frame: 16 weeks

    ALT (Alanine Aminotransferase) is an indicator that can reflect liver function damage,which is measured in blood .

  2. CK18

    Time frame: 16 weeks

    Cell corner fragment 18 (CK18) is mainly used as a specific indicator for evaluating liver cell apoptosis, which can help us understand the degree and nature of liver damage. CK18 is measured in blood.

  3. FIB-4

    Time frame: 16 weeks

    The Fibrosis 4 Score (FIB-4) is a non-invasive indicator for assessing the degree of liver fibrosis in patients with chronic liver disease. This scoring system calculates the degree of liver fibrosis using simple blood indicators, including age, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and platelet count (PLT).

  4. LSM

    Time frame: 16 weeks

    The LSM score, also known as Liver Stiffness Measurement, is an indicator used to evaluate the degree of liver fibrosis through FibroScan.

  5. body weight

    Time frame: 16 weeks

    body weight

  6. waist circumference

    Time frame: 16 weeks

    waist circumference

  7. hip circumference

    Time frame: 16 weeks

    hip circumference

  8. waist to hip ratio

    Time frame: 16 weeks

    waist to hip ratio

  9. Waist hip height ratio

    Time frame: 16 weeks

    Waist hip height ratio

  10. Self-Rating Anxiety Scale

    Time frame: 16 weeks

    The Self Rating Anxiety Scale is used to assess an individual's anxiety symptoms

  11. Self-rating depression scale

    Time frame: 16 weeks

    Self rating depression scale is used to assess an individual's depressive symptoms

  12. Pittsburgh sleep quality index

    Time frame: 16 weeks

    Pittsburgh sleep quality index is used to evaluate an individual's sleep status

  13. Damp Heat Traditional Chinese Medicine Syndrome Scale

    Time frame: 16 weeks

    Damp Heat Traditional Chinese Medicine Syndrome Scale is used to evaluate individual damp heat syndrome

Study contacts

Contact information is provided by the study sponsor or research team.

Zhi Wang

CONTACT

[email protected]

13487095852

Sponsors and collaborators

Lead sponsor

Dong Hui

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 27, 2025
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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