Randomized controlled evaluation and multi-omics mechanism study of Xinjia Shiwei Wendan Decoction in the treatment of metabolism-associated fatty liver disease.

Authors
Category Primary study
Registry of TrialsInternational Traditional Medicine Clinical Trial Registry
Year 2026
INTERVENTION: 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, Ziziphi spinosae semen 15g, Crataegi fructus 15g, prepared Polygalae radi X10g, honey‐fried Glycyrrhizae radi Xet rhizoma 10g, processed Codonopsis radi X15g, Salviae miltiorrhizae radi Xet rhizoma 15g, ginger‐prepared Bambusae caulis in taeniam 10g), administered twice daily plus lifestyle intervention.;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.; CONDITION: Metabolism‐associated fatty liver disease PRIMARY OUTCOME: Controlled Attenuation Parameter;Liver Stiffness Measurement;Low‐density lipoprotein cholesterol;High‐density lipoprotein cholesterol;Triglyceride;Total cholesterol; SECONDARY OUTCOME: 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; 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.
Epistemonikos ID: ad4d078af3711d1cd741cb0e1227cd7b9858f117
First added on: Aug 08, 2026