MAFLD
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 18-65 years old, regardless of gender; 2. Meet both Chinese and Western medical diagnostic standards; 3. Above the normal upper limit<serum ALT<=3 times the normal upper limit. 4. Fasting blood glucose<=7.0mmol/L; 5. Sign an informed consent form; 6. Those who have not taken other drugs for the treatment of non-alcoholic steatohepatitis, or have stopped using other drugs for NASH before being included in observation for 4 weeks.
Exclusion criteria
Exclusion criteria: 1) With other acute or chronic liver diseases. 2) Patients with combined serious primary diseases of the heart, brain, kidney and haematopoietic system. 3) Patients with acute fatty liver of pregnancy, lipoid deposition disease, focal fatty liver, hepatic fatty tumour, etc. 4) Patients with mental illness. 5) Women who are pregnant or preparing for pregnancy, breastfeeding women. 6) Unstable weight (>5% change in the previous 3 months). 7) Patients with diabetes mellitus who are being treated with insulin or oral hypoglycaemic agents; 8) Current use of medications (e.g., weight-loss medications, etc.) that may interfere with the action, absorption, or disposition of the study treatment, or clinical studies. 9) Contraindications to MRI (pacemakers, Klaus phobia, implantation of medical devices with ferromagnetic properties). 10) Patients with allergic idiosyncrasies. 11) Those who are unable to follow the treatment protocol to the letter. 12) Patients with previous or planned bariatric surgery during the study period. 13) Participation in an investigational new drug clinical study within 30 days prior to randomisation. 14) Any other condition that, in the opinion of the investigator, may impede compliance, prevent completion of the study, harm the health of the subject, or interfere with study outcomes. Translated with www.DeepL.com/Translator (free version)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRI-PDFF; | — |
Secondary
| Measure | Time frame |
|---|---|
| ALT;AST;CAP;BMI;TG;TC;HDL;LDL;BFR;WHR; | — |
Countries
China
Contacts
Shuguang Hospital, Shanghai University of Traditional Chinese Medicine