Metabolic Associated Fatty Liver Disease
Conditions
Interventions
Pueraria Radix Group:Puerariae Radix Granules
Sponsors
Nanjing Lishui District People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Western Medicine Diagnosis: Meeting the diagnostic criteria for Non-Alcoholic Fatty Liver Disease (NAFLD) without a history of excessive alcohol consumption (males: =210g ethanol per week; females: =140g ethanol per week); excluding other liver diseases such as viral hepatitis and drug-induced liver injury; abdominal ultrasound or MRI indicating diffuse fatty liver, or persistent elevation of serum ALT/GGT for =6 months.? Traditional Chinese Medicine (TCM) Syndrome Type: Referring to the Expert Consensus on Integrated 2.Traditional Chinese and Western Medicine Diagnosis and Treatment of Non-Alcoholic Fatty Liver Disease (2025), the syndrome is differentiated as phlegm-turbidity internal obstruction syndrome or damp-heat accumulation syndrome. For phlegm-turbidity internal obstruction syndrome, it is required to meet =2 main symptoms (obesity, discomfort in the right hypochondrium, general lassitude and heaviness, sticky stool) + =1 secondary symptom, along with pale tongue with white greasy coating and deep slippery pulse; for damp-heat accumulation syndrome, it is required to meet =2 main symptoms (distending pain in the right hypochondrium, sticky stool, epigastric and abdominal distension) + =1 secondary symptom, along with red tongue with yellow greasy coating and wiry slippery pulse.? 3.Age Range: 18-80 years old, male or female.? 4.Liver Fat Content: MRI-PDFF 5%-66% (mild to moderate fatty liver) or CAP value 238-292 db/m.? 5.Informed Consent: Voluntarily participating in this study, signing the informed consent form, and promising to comply with lifestyle interventions and follow-up requirements during the study period.
Exclusion criteria
Exclusion criteria: 1. Severe Liver Disease Types: Patients with non-alcoholic steatohepatitis (NASH) cirrhosis, hepatocellular carcinoma, and acute liver failure; 2. Complicated with Severe Diseases: Complicated with type 1 diabetes mellitus, poorly controlled type 2 diabetes mellitus (T2DM), severe obesity (BMI =40 kg/m²), dysfunction of important organs such as heart, liver and kidney, malignant tumors, or severe mental disorders; 3. Women who are pregnant, lactating, or planning to become pregnant; 4. A history of allergy to Pueraria Radix in the past; 5. Patients with poor expected compliance or language communication disorders; 6. Currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CAP value for hepatic fat content (dB/m); | — |
Secondary
| Measure | Time frame |
|---|---|
| Alanine Aminotransferase;Aspartate Aminotransferase;Gamma-Glutamyl Transferase;Total Cholesterol;Triglyceride;High-Density Lipoprotein;Low-Density Lipoprotein;Fasting Blood Glucose;Homeostasis Model Assessment of Insulin Resistance;TCM Syndrome Score; | — |
Countries
China
Contacts
Public ContactChunyan Fan
Nanjing Lishui District People's Hospital
Outcome results
None listed