MAFLDPhase 2NCT06848907
Clinical Study on the Treatment of MAFLD With Ganzhixiao Capsules
A Phase 2 study testing ganzhixiao capsule in people with MAFLD, run by Dong Hui.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- MAFLD
- What is being tested?
- ganzhixiao capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2025to 30 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Re Evaluation of the Clinical Efficacy of Ganzhixiao Capsules Based on MRI-PDFF in the Treatment of Metabolic Related Fatty Liver Disease
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.
Read the 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.
- Conditions
- MAFLD
- Being tested
- ganzhixiao capsule, placebo capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ganzhixiao capsuleDrug
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 capsuleDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Clinical study on the treatment of MAFLD with palcebo capsules | Placebo comparator | Not described Receives: Drug: placebo capsule |
| Clinical study on the treatment of MAFLD with Ganzhixiao capsules | Experimental | Not described Receives: Drug: ganzhixiao capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI-PDFF
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 (%).
Measured: 16 weeks
Secondary outcomes (13)
ALT
ALT (Alanine Aminotransferase) is an indicator that can reflect liver function damage，which is measured in blood .
Measured: 16 weeks
CK18
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.
Measured: 16 weeks
FIB-4
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).
Measured: 16 weeks
LSM
The LSM score, also known as Liver Stiffness Measurement, is an indicator used to evaluate the degree of liver fibrosis through FibroScan.
Measured: 16 weeks
body weight
body weight
Measured: 16 weeks
waist circumference
waist circumference
Measured: 16 weeks
hip circumference
hip circumference
Measured: 16 weeks
waist to hip ratio
waist to hip ratio
Measured: 16 weeks
Waist hip height ratio
Waist hip height ratio
Measured: 16 weeks
Self-Rating Anxiety Scale
The Self Rating Anxiety Scale is used to assess an individual's anxiety symptoms
Measured: 16 weeks
Self-rating depression scale
Self rating depression scale is used to assess an individual's depressive symptoms
Measured: 16 weeks
Pittsburgh sleep quality index
Pittsburgh sleep quality index is used to evaluate an individual's sleep status
Measured: 16 weeks
Damp Heat Traditional Chinese Medicine Syndrome Scale
Damp Heat Traditional Chinese Medicine Syndrome Scale is used to evaluate individual damp heat syndrome
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start30 May 2025 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong Hui
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dong Hui, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848907
- Sponsor's protocol ID
- TJ-IRB202504027
- Status last verified
- May 2025
- First submitted
- 15 Feb 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re Evaluation of the Clinical Efficacy of Ganzhixiao Capsules Based on MRI-PDFF in the Treatment of Metabolic Related Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT06848907
- Acronym / sponsor ID
- TJ-IRB202504027
- Conditions
- MAFLD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Dong HuiUniversity, hospital or other
- Study start
- 30 May 2025 (estimated)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical study on the treatment of MAFLD with palcebo capsules | Placebo comparator | Drug: placebo capsule |
| Clinical study on the treatment of MAFLD with Ganzhixiao capsules | Experimental | Drug: ganzhixiao capsule |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ganzhixiao capsuleGanzhixiao 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 | Clinical study on the treatment of MAFLD with Ganzhixiao capsules |
| placebo capsuleTake 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. | Drug | Clinical study on the treatment of MAFLD with palcebo capsules |
Primary outcome
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 (%).
13 secondary outcomes
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
Damp Heat Traditional Chinese Medicine Syndrome Scale
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ganzhixiao capsule in people with MAFLD, run by Dong Hui.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhi Wang (13487095852, 2410216693@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI-PDFF (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.