Metabolic associated fatty liver disease
Conditions
Interventions
test group:Qizhen granules
control groups:Placebo granules
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Meet the clinical diagnostic criteria of metabolic fatty liver disease (MAFLD) in the Guidelines for the Prevention and Control of Metabolic (Non-alcoholic) Fatty Liver Disease (2024 Edition); 2) Chinese medicine diagnosis belongs to the syndrome of liver depression and spleen deficiency; 3) Age =18 years old and =65 years old gender is not limited; 4) In case of diabetes mellitus maintain the original glucose-lowering medication regimen and lifestyle unchanged and the glycated hemoglobin ranges from 6.5 to 8.9% and fluctuates no more than 0.5% within three months; 5) In case of hypertension and hyperlipidemia use standardized antihypertensive drugs and lipid-lowering drugs for 1 month before enrollment. 8.9% and the fluctuation is not more than 0.5% within three months; 5) If combined with hypertension and hyperlipidemia use standardized antihypertensive drugs and lipid-lowering drugs for =1 month before enrollment adjust the dose according to individual efficacy and tolerance and maintain the stable range; 6) Understand agree to participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) alcohol drug viral hepatitis autoimmune disorders and infections caused by other types of fatty liver; 2) aspartate aminotransferase (AST) and/or glutamic transaminase (ALT) is higher than the upper limit of the normal value of five times; 3) MAFLD progression to cirrhosis or liver cancer; 4) pregnancy or preparation for pregnancy breastfeeding women; 5) combined with renal digestive hematopoietic and other serious diseases combined with the cardio-pulmonary Serious insufficiency of cardiopulmonary function; 6) Fasting blood glucose > 9 mmol/L glycosylated hemoglobin = 9.0%; triglycerides = 2.3 mmol/L (200 mg/dl) total cholesterol = 6.2 mmol/L (240 mg/dl) LDL cholesterol = 4.1 mmol/L (160 mg/dl); systolic blood pressure = 140 mmHg and/or Diastolic blood pressure =140 mmHg and/or =90 mmHg; 7)patients with known allergy to the test drug or its components; 8)those who had adjusted lipid-lowering liver and enzyme-lowering drugs or taken weight-loss pills within 1 month prior to enrollment; 9) those who had participated in or were currently participating in other interventional clinical studies within 3 months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CAP; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2hPG;IL-6;FCP;HOMA-IR;hs-CRP;LDL-C;AST;BMI;ALT;HDL-C;TG;TNF-a;SOD;FPG;MDA;TC;FINS; | — |
Countries
China
Contacts
Public ContactHongjie Yang
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine
Outcome results
None listed