Metabolic Associated Fatty Liver Disease (MAFLD)-Related Liver Fibrosis
Conditions
Interventions
Experimental Group:Biejiajian Pills
Placebo group:Biejiajian Pills Simulant
Sponsors
Gulou Hospital Affiliated to Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: (1) Age 18-75 years, any gender; (2) Previously diagnosed with MAFLD; (3) Liver fibrosis confirmed by MRE (3kPa = LSM-MRE <5kPa); (4) No prior use of anti-fibrotic medications within 6 months (including but not limited to Fuzhenghuayu Capsules/Tablets, Compound Biejia Ruangan Tablets, Anluo Huaxian Pills, etc.); (5) Voluntary signed informed consent; (6) Willingness to comply with treatment and follow-up.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: (1) Liver fibrosis caused by non-MAFLD etiologies (e.g., viral hepatitis, autoimmune diseases, hemochromatosis); (2) Clinical evidence/history of cirrhosis (F4) or decompensated liver disease; (3) Prior portosystemic shunt surgery; (4) Laboratory exclusions: AFP >20 ng/mL, TBIL >1.3×ULN, ALT/AST >5×ULN, ALP >2×ULN, ALB 1.3, HbA1c >9.5%, platelets 140g/week for females, >210g/week for males); (10) Conditions affecting drug absorption; (11) Gastric emptying abnormalities; (12) Recent bariatric surgery/weight-loss devices; (13) >5% weight fluctuation within 6 months; (14) Endocrine-related obesity; (15) Non-T2DM diabetes; (16) Uncontrolled T2DM complications; (17) HIV-positive; (18) TPN within 6 months; (19) NYHA Class III-IV heart failure; (20) Acute cardiovascular events within 6 months; (21) Uncontrolled hypertension (=160/100 mmHg); (22) QTc >500 ms or long QT syndrome; (23) Unstable antidiabetic regimens; (24) Unstable lipid/weight medications; (25) Drug allergies; (26) Concurrent clinical trials; (27) Pregnancy/lactation or inadequate contraception; (28) MRI contraindications; (29) Recent use of GLP-1 agonists/MASH therapies; (30) Other investigator-determined exclusions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with =19% reduction in MRE-assessed liver stiffness measurement (LSM) from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change and change rate in FibroScan-assessed liver stiffness measurement (LSM) from baseline;Change and change rate in MRE-assessed liver stiffness measurement (LSM) from baseline;Change and change rate in MRI-PDFF-assessed hepatic steatosis from baseline;Proportion of patients with =30% relative reduction in MRI-PDFF-assessed hepatic steatosis from baseline;Change and change rate in FibroScan-controlled attenuation parameter (CAP) from baseline;Change and change rate in liver function from baseline;Change and change rate in blood glucose levels from baseline;Change and change rate in blood lipid levels from baseline;Change and change rate in quality of life scores from baseline;Change in Traditional Chinese Medicine (TCM) symptom scores from baseline;Change and change rate in body mass index (BMI) from baseline;Change and change rate in cytokeratin-18 (CK-18) levels from baseline;MASH Resolution Index; | — |
Countries
China
Contacts
Public ContactLi Jie
Gulou Hospital Affiliated to Nanjing University Medical School
Outcome results
None listed