non-alcoholic fatty liver disease (NAFLD)
Conditions
Interventions
Intervention group:The same lifestyle intervention as the control group combined with Wulingsan granules
control group:lifestyle intervention
Sponsors
Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meeting the clinical diagnostic criteria for NAFLD; (2) Meeting the diagnostic criteria for the syndrome of internal retention of damp-turbidity;(3) Aged between 18 and 65 years old; (4) Having a body mass index (BMI) of at least 24 kg/m² and with a weight change of no more than 5% within 6 weeks; (5) MRI-PDFF = 10%;(6) The upper limit of normal (ULN) = ALT = 5 times ULN; (7) Voluntarily participating in this study and signing the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Hepatoprotective and enzyme-lowering drugs that affect the evaluation of treatment efficacy within the past 3 months;(2) Bilirubin elevation exceeding 1.5 times the upper limit of normal (ULN) or alkaline phosphatase = 2 times ULN;(3) Liver stiffness measurement (LSM) by transient elastography = 8.0 kPa;(4) Suffering from type 1 diabetes or gestational diabetes; or having unstable blood glucose control (HbA1c > 9.0%) within 3 months before enrollment in type 2 diabetes or a change in the type of oral or injectable antidiabetic drugs; (5) Using thiazolidinediones (pioglitazone rosiglitazone) GLP-1 receptor agonists sodium-glucose cotransporter 2 inhibitor drugs CYP2C8 inhibitors/substrates or taking vitamin E > 100 IU/day within 3 months before the screening visit; within 3 months before the screening visit adding or changing the dosage of statins (simvastatin pitavastatin pravastatin atorvastatin fluvastatin lovastatin rosuvastatin) or fibrates (clofibrate fenofibrate). (6) Suffering from other serious diseases such as malignant tumors cardiorespiratory diseases or severe renal insufficiency; (7) Having a history of neurological diseases or mental illnesses;(8) Being pregnant breastfeeding or planning to become pregnant during the study period;(9) Being allergic to the relevant drugs used in the clinical study; (10) Having poor expected compliance or participating in other clinical trials; (11) Using weight loss drugs or participating in weight loss programs within the past 3 months;(12) Wearing a pacemaker or metal implants having claustrophobia or other conditions that prevent magnetic resonance examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| liver fat content; | — |
Secondary
| Measure | Time frame |
|---|---|
| chronic liver disease questionnaire for NAFLD;Fasting blood glucose;four indexes for liver fibrosis;HOMA-IR;Traditional Chinese Medicine Syndrome Score Scale;Weight, waist circumference, abdominal circumference, hip circumference, BMI;Four lipid indicators (Triglyceride, Total Cholesterol, Low - Density Lipoprotein, High - Density Lipoprotein);Liver function (ALT, AST, TBIL, ALP and GGT);Liver fat attenuation parameter (CAP) and liver stiffness measurement (LSM);Ultrasonically measure the severity of fatty liver;HbA1c; | — |
Countries
China
Contacts
Public ContactQingfeng Du
Southern Medical University Hospital of Integrated Tradnional Chinese and Western Medicine
Outcome results
None listed