Clinical study of metabolic associated fatty liver disease
- Conditions
- metabolic associated fatty liver disease
- Registration Number
- ITMCTR2022000064
- Lead Sponsor
- China Academy of traditional Chinese medicine Guang an Men hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
? Meet the diagnostic criteria of Chinese and Western medicine for MAFLD; ? Between 18 and 65 years old; ? Those who have good compliance, are willing to participate in the study, complete all procedures and follow-up of the study, and sign informed consent.
? Pregnant or lactating women; ? With serious diseases of important organs (such as heart, brain, lung and kidney); ? Clearly diagnosed as infectious hepatitis, liver biopsy has confirmed as cirrhosis, liver cancer patients; Or drug-induced liver disease, genetic factors and other specific diseases that can lead to fatty liver; (4) mentally and legally disabled patients; ? Suspected or had a history of drug abuse; Alcohol intake =40g/d for males and =20g/d for females; Or heavy drinking history within 2 weeks, equivalent to alcohol > 80g/d; ? Known to be allergic to the drug components; ? Exercise contraindications; ? Had used antibiotics, living bacteria preparations, hormone drugs, immunosuppressants and other preparations that may affect intestinal flora in the past 1 month; Or have used hypoglycemic, lipid-regulating and liver-protecting drugs in recent 1 month; ? Patients with ALT=3ULN or FPG=7.0mmol/L and no previous hypoglycemic drugs; ? Patients who are participating in clinical trials of other drugs; Or have participated in a drug clinical trial within the past one month.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method controlled attenuation parameter;
- Secondary Outcome Measures
Name Time Method Waist-Hip Ratio;blood lipids;TCM symptom score;liver stiffness measurement;blood pressure;Glycated hemoglobin;Body Mass Index;liver functions;Fasting blood sugar;uric acid;Intestinal microflora structure;Short Chain Fatty Acids;Highigh - sensitivity C - Reactive protein;Abdominal Ultrasound;