ITMCTR2022000064
Not yet recruiting
Phase 1
A pragmatic randomized controlled clinical study of Tiaogan Huazhuo Decoction combined with exercise therapy in the treatment of metabolic associated fatty liver disease
China Academy of traditional Chinese medicine Guang an Men hospital0 sitesTBD
Conditionsmetabolic associated fatty liver disease
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- metabolic associated fatty liver disease
- Sponsor
- China Academy of traditional Chinese medicine Guang an Men hospital
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •? 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.
Exclusion Criteria
- •? 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.
Outcomes
Primary Outcomes
Not specified
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