Metabolism-associated fatty liver disease
Conditions
Interventions
Chinese medicine group:Xinjia Shiwei Wendan Decoction (composed of Poria cocos 15g, Citri reticulatae pericarpium 10g, bran-fried Aurantii fructus immaturus 10g, ginger-prepared Pinellia ternata 9g, Z
Western medicine group:Atorvastatin calcium tablets (10mg, once every night) plus lifestyle intervention.
Chinese medicine and Western medicine combination group:Xinjia Shiwei Wendan Decoction plus atorvastatin calcium tablets (10mg) plus lifestyle intervention.
Sponsors
Foshan Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 78 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for metabolic-associated fatty liver disease in Western medicine; 2. Aged 18 to 78 years, with no restriction on gender, and patients with steatosis grade mild to moderate and fibrosis grade F0–F2; 3. Has lipid abnormalities: elevated serum triglycerides, elevated total cholesterol, or reduced low-density lipoprotein; 4. Meets the diagnostic criteria for spleen deficiency with phlegm-dampness in traditional Chinese medicine; 5. Has not used drugs that may affect liver function, lipid levels, etc., within the past 4 weeks prior to enrollment in the clinical study; 6. Is able to cooperate with the required examinations, tests, and collection of traditional Chinese medicine four-diagnosis information, and willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Diabetes mellitus; 2. Metabolic-associated fatty liver disease (MAFLD) has progressed to cirrhosis (fibrosis stage F3-F4) or hepatocellular carcinoma; 3. Liver function > 3 times the upper limit of normal (ULN) and/or renal function > 1.5 times ULN; 4. Other chronic liver diseases, excluding alcoholic liver disease, viral hepatitis, drug-induced liver injury, autoimmune hepatitis, or primary biliary cholangitis, which may cause fatty liver; 5. Coexisting severe diseases, such as malignant tumors, cardiovascular diseases, or mental disorders; 6. Allergic constitution or allergy to the investigational drug used in this study; 7. Pregnant women, those planning to conceive, or breastfeeding women; 8. Receipt of relevant treatment drugs within the past month. If any of the above conditions are met, the participant will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Controlled Attenuation Parameter;Liver Stiffness Measurement;Low-density lipoprotein cholesterol;High-density lipoprotein cholesterol;Triglyceride;Total cholesterol; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body weight;Waist circumference;Body Mass Index;Fasting blood glucose;Homeostasis Model Assessment of Insulin Resistance;Alanine Aminotransferase;Aspartate Aminotransferase;TCM Syndrome Score;Creatinine;Adverse Event Incidence Rate; | — |
Countries
China
Contacts
Public ContactQiuSheng Xiao
Foshan Hospital of Traditional Chinese Medicine
Outcome results
None listed