metabolic dysfunction-associated fatty liver disease
Conditions
Interventions
Experimental group:Jiangzhi Granules+Lifestyle Intervention
Control group:Placebo+Lifestyle Intervention
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18–65 years, any gender; 2.MAFLD diagnostic criteria with BMI =24 kg/m² and liver MRI-PDFF =5%; 3.Damp-heat syndrome confirmed by TCM pattern differentiation (PRO scale score =29 points); 4.Provided written informed consent, agreed to comply with all study visits and examinations.
Exclusion criteria
Exclusion criteria: 1.Excessive alcohol consumption (defined as >140g/week for men or >70g/week for women in the past 6 months); 2.Dysregulated glucose/lipid metabolism (TG =1.7 mmol/L or LDL-C =3.4 mmol/L and/or FPG =6.1 mmol/L or 2hPG =7.8 mmol/L or HbA1c =5.7%); 3.Severe MAFLD (MRI-PDFF =25%); 4.Other liver diseases: Alcoholic/acute/chronic viral/drug-induced/autoimmune/genetic liver disease, cirrhosis, HCC; or ALT >5×ULN; 5.Severe comorbidities: Cardiovascular, cerebral, renal, or hematopoietic system diseases; 6.Metabolism-affecting disorders: Hyper-/hypothyroidism, Cushing's syndrome; 7.Recent medication (within 3 months): Pioglitazone, GLP-1RAs, DPP-4 inhibitors, insulin, glycyrrhizic acid; 8.Renal impairment (serum creatinine >106.8 µmol/L); 9.MRI contraindications: Cardiac pacemakers, claustrophobia, ferromagnetic implants; 10.Pregnancy (current or planned within 1 year); 11.Recent antibiotics/PPIs (within 1 month); 12.Hepatotoxic drugs (e.g., glucocorticoids, methotrexate for =2 weeks within 3 months); 13.Concurrent clinical trials (within 4 weeks); 14.Investigator discretion for unsuitability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HepaticBFat Content(MRI-PDFF); | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver Stiffness Measurement(LSM);changes in liver biopsy pathological scores;Liver function, glucose and lipid metabolism indexes,Damp-heat syndrome Scale,Anthropometric Measures; | — |
Countries
China
Contacts
Public ContactLianjun Xing
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed