Metabolism-related fatty liver disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria of MASLD Western Medicine; (2) TCM syndrome type is consistent with liver-stagnation and spleen-deficiency syndrome; (3) Age = 18 years old and ?80 years old, gender is not limited; (4) Liver function ALT, AST or GGT can be mildly to moderately elevated (not more than 5 times the upper limit of normal); (5) Subjects must agree to participate in the study and voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: (1) steatosis and inflammation related factors that may be caused by alcoholic liver disease, hepatolenticular degeneration, autoimmune liver disease, chronic viral hepatitis, inflammatory bowel disease, total parenteral nutrition, hypothyroidism, ß-lipoprotein deficiency, Cushing's syndrome, insulin resistance related syndrome, and drugs; (2) with serious underlying diseases, mental diseases (hematopoietic system and liver, kidney, cardiovascular and cerebrovascular and other serious primary diseases, malignant tumors, other serious comorbidities or mental disorders); (3) People who are allergic or known to be allergic to the components of this medicine; (4) Women during pregnancy or preparing for pregnancy or breastfeeding; (5) Those who have taken liver protection drugs and antioxidants for a long time; (6) People who have recently taken or are taking drugs that cause elevated aminotransferase; (7) Severe liver function impairment, total bilirubin > 51umol/L, ALT>400U/L, AST>400U/L; Patients with cirrhosis or hepatocellular carcinoma; (8) Those who are participating in other clinical trials or have participated in other clinical trials in the last 3 months; (9) Suspected substance abuse history or other ineligible subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TCM syndrome score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver enzyme index;serum lipids;fasting blood sugar;glycosylated hemoglobin;Fasting insulin;BMI;Controlled attenuation parameters;visceral fat;Liver hardness number;body fat rate;Tumor necrosisfactor-a,TNF-a;Interleukin 6, IL-6;Pittsburgh Sleep Quality Index Scale;Nonalcoholic Fatty Liver Fibrosis Score (NFS Score);FIB-4 score; | — |
Countries
China
Contacts
Yueyang Hospital of Integrated Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine