Metabolic dysfunction-associated fatty liver disease
Conditions
Interventions
Control Group:Basic treatment + Polyene phosphatidylcholine capsules
Experimental Group:Basic treatment + Shuang Huang Fen Xiao Fang
Sponsors
Shanghai University of Traditional Chinese Medicine Affiliated Municipal Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The diagnosis meets the diagnostic criteria for MAFLD, with liver fibrosis at the F2-F3 stage; ALT and AST levels =5ULN; bilirubin levels =2ULN; 2. The diagnosis meets the diagnostic criteria for the damp-heat and stasis type; 3. Aged between 18-65 years, with no restriction on gender; 4. Capable of cooperating to observe therapeutic effects and adverse events, as well as recording the participant's diary; 5. Voluntarily participating in this study and signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with cirrhosis, hepatocellular carcinoma; patients with severe diabetes, severe cardiovascular and cerebrovascular diseases; 2. Patients who have taken other lipid-lowering, antidiabetic, or weight-loss drugs that may affect the assessment of efficacy (e.g., statins, niacin, fibrates, bile acid sequestrants, etc.) within 4 weeks prior to enrollment; 3. Patients with active viral hepatitis, autoimmune hepatitis, primary biliary cholangitis, drug-induced or toxic hepatitis, alcoholic liver disease, or other conditions that may lead to fatty liver; 4. Pregnant or breastfeeding women, and women planning to become pregnant during the study period; 5. Patients with severe primary diseases of the circulatory, respiratory, digestive, or hematopoietic systems (e.g., coronary artery disease, heart failure, COPD, severe bronchial asthma, major gastrointestinal bleeding, malignant hematological diseases, severe coagulation disorders, marrow failure diseases, etc.), or severe diseases affecting survival (e.g., malignant tumors); 6. Patients with mental abnormalities who are unable to cooperate with this study; 7. Patients who are unsuitable for drug trial observations, or who are unable to comply with treatment, making it difficult to accurately assess the efficacy and safety of the drug; 8. Patients with allergic constitutions or known allergies to the components of the Shuanghuangfenshao formula; 9. Patients participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver Stiffness Measurement; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver fat content;Controlled Attenuation Parameter;Liver fat content;AST to Platelet Ratio Index , Fibrosis-4 Score, and early liver fibrosis biomarkers (such as Hyaluronic Acid, Laminin, Procollagen Type III, Collagen Type IV);Carbohydrate and lipid metabolism and liver function;Traditional Chinese Medicine Syndrome Score;Body Mass Index and Waist-to-Hip Ratio; | — |
Countries
China
Contacts
Public ContactNie Hongming
Shanghai Traditional Chinese Medicine Hospital
Outcome results
None listed