MAFLD
Conditions
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.
Interventions
DRUGganzhixiao capsule
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.
DRUGplacebo capsule
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.
Sponsors
Dong Hui
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRI-PDFF | 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
| Measure | Time frame | Description |
|---|---|---|
| CK18 | 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. |
| FIB-4 | 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). |
| LSM | 16 weeks | The LSM score, also known as Liver Stiffness Measurement, is an indicator used to evaluate the degree of liver fibrosis through FibroScan. |
| body weight | 16 weeks | body weight |
| waist circumference | 16 weeks | waist circumference |
| hip circumference | 16 weeks | hip circumference |
| ALT | 16 weeks | ALT (Alanine Aminotransferase) is an indicator that can reflect liver function damage，which is measured in blood . |
| Waist hip height ratio | 16 weeks | Waist hip height ratio |
| Self-Rating Anxiety Scale | 16 weeks | The Self Rating Anxiety Scale is used to assess an individual's anxiety symptoms |
| Self-rating depression scale | 16 weeks | Self rating depression scale is used to assess an individual's depressive symptoms |
| Pittsburgh sleep quality index | 16 weeks | Pittsburgh sleep quality index is used to evaluate an individual's sleep status |
| Damp Heat Traditional Chinese Medicine Syndrome Scale | 16 weeks | Damp Heat Traditional Chinese Medicine Syndrome Scale is used to evaluate individual damp heat syndrome |
| waist to hip ratio | 16 weeks | waist to hip ratio |
Contacts
Primary ContactZhi Wang
Outcome results
None listed