Clinical evaluation of Kang's Ling-He Granules in the treatment of obese metabolic-related fatty liver disease
- Conditions
- Metabolically associated fatty liver disease
- Registration Number
- ITMCTR2200006024
- Lead Sponsor
- Xiamen Hospital of TCM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
Referring to diagnostic criteria for MAFLD based on the new definition of metabolic fatty liver disease in 2020, the diagnostic criteria of Phlegm, Dampness and Blood Stasis Syndrome established by the consensus opinion on the diagnosis and treatment of non-alcoholic fatty liver disease by integrated traditional Chinese and western medicine (2017) are as follows::?Age 18-60 years; ?Compliance with MAFLD (obesity type) diagnostic criteria and TCM phlegm, dampness, blood stasis syndrome diagnostic criteria; ?24=BMI<30kg/m2; ?MRI PDFF > 8 %, willing to accept regular physical and chemical examinations; ?Sign informed consent.
?Alanine aminotransferase / aspartate aminotransferase > 5 × ULN ( standard upper limit ), total bilirubin > 2 × ULN; ?Alcoholic fatty liver disease; ?Combined with viral, autoimmune and other liver diseases, or taking drugs that may cause fatty liver; ?Combined with diabetes, malignant tumors, connective tissue diseases and severe heart, liver, hematopoietic, and nervous system complications , Or clearly have other important diseases; ?TCM Syndrome Differentiation of Liver and Kidney Yin Deficiency, Spleen and Kidney Yang Deficiency and Other Typical Deficiency Syndrome; ?Pregnant or breastfeeding women, allergic physique, allergic to drugs, and patients with mental illness; ?Patients who have undergone gastrointestinal bariatric surgery within the past year or who have taken weight-loss drugs within the past three months have lost >10%; ?Patients who took other therapeutic drugs in the past three months affected efficacy evaluation or participated in other clinical trials in the past month.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MRI PDFF;
- Secondary Outcome Measures
Name Time Method Fibro Touch (CAP);weight;waist;blood fat;liver function;Uric Acid;blood glucose test;Self-made PRO Symptoms and Signs Scale;