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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.
All participants in the trial were required to have a low-fat diet and engage in aerobic exercise for 150 minutes per week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical study on the treatment of MAFLD with palcebo capsules | Placebo Comparator |
| |
| Clinical study on the treatment of MAFLD with Ganzhixiao capsules | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 (%). | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ALT | ALT (Alanine Aminotransferase) is an indicator that can reflect liver function damage,which is measured in blood . | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhi Wang | Contact | 13487095852 | 2410216693@qq.com |
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| 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. |
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| 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). | 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. | 16 weeks |
| body weight | body weight | 16 weeks |
| waist circumference | waist circumference | 16 weeks |
| hip circumference | hip circumference | 16 weeks |
| waist to hip ratio | waist to hip ratio | 16 weeks |
| Waist hip height ratio | Waist hip height ratio | 16 weeks |
| Self-Rating Anxiety Scale | The Self Rating Anxiety Scale is used to assess an individual's anxiety symptoms | 16 weeks |
| Self-rating depression scale | Self rating depression scale is used to assess an individual's depressive symptoms | 16 weeks |
| Pittsburgh sleep quality index | Pittsburgh sleep quality index is used to evaluate an individual's sleep status | 16 weeks |
| Damp Heat Traditional Chinese Medicine Syndrome Scale | Damp Heat Traditional Chinese Medicine Syndrome Scale is used to evaluate individual damp heat syndrome | 16 weeks |