MAFLD
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients meeting the diagnostic criteria for MAFLD in Western medicine; 2. Patients meeting the diagnostic criteria for dampness and turbidity obstruction syndrome in Traditional Chinese Medicine; 3. Patients aged =18 years and =75 years; 4. Overweight/obese: BMI = 24 kg/m², or waist circumference: = 90 cm for men and = 85 cm for women; 5. If there is abnormal glucose metabolism or type 2 diabetes: fasting blood glucose = 6.1 mmol/L, or 2-hour postprandial blood glucose = 7.8 mmol/L, or HbA1c = 5.7%, or a history of type 2 diabetes, or HOMA-IR = 2.5; 6. If there is abnormal lipid metabolism: fasting serum triglycerides = 1.7 mmol/L, or on lipid-lowering drug treatment; or serum high-density lipoprotein cholesterol - = 1.0 mmol/L for men and = 1.3 mmol/L for women, or on lipid-lowering drug treatment; 7. If there is abnormal liver function: ALT or AST or ?GT = 1 ULN, or on liver enzyme-lowering drug treatment; 8. Patients who have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with other chronic liver diseases such as other viral liver diseases autoimmune liver diseases alcoholic liver diseases drug-induced liver diseases or liver malignancies; 2. Patients with Child-Pugh grade > A; 3.Pregnant or lactating women women of childbearing age who have not taken effective contraceptive measures or male subjects who are unwilling to use contraceptive measures; 4.Patients with severe primary cardiovascular diseases kidney diseases hematological diseases lung diseases tumors AIDS or other serious diseases that affect survival; such as abnormal renal function creatinine higher than the upper limit of normal. Clinically significant arrhythmias. 5.Patients without or with limited capacity for civil conduct; 6.Patients suspected or confirmed to have a history of alcohol or drug abuse; 7.Patients known to be allergic to the components of this medicine; 8.Patients who have participated in other clinical trials within the past 3 months; 9. Patients who have used traditional Chinese medicines or Chinese patent medicines with the same or similar efficacy as Qinghua Formula within the past month; 10. Patients deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver CAP; | — |
Secondary
| Measure | Time frame |
|---|---|
| liver B-ultrasound;TCM syndrome score; | — |
Countries
China
Contacts
Longhua Hospital Shanghai University of Traditional Chinese Medicine