A randomized controlled trial for the efficacy and safety of Gan-Jiang Ling-Zhu decoction in the treatment of lean nonalcoholic fatty liver disease with pattern of ''yang deficiency and fluid retention''

onghua Hospital, Shanghai University of Traditional Chinese Medicine0 sitesStarted: TBDLast updated: February 20, 2023

Conditions

Trial Snapshot

No summary available.

•1. aged 18-70 years old;
•2. Meet the diagnostic criteria of nonalcoholic fatty liver disease;
•3. Meet the diagnostic criteria of pattern of yang deficiency and fluid retention;
•4. BMI<23kg/m2
•5. Agree to participate in this clinical study, voluntarily sign the informed consent, and agree to participate in all visits, examinations and treatments as required by the study plan.

•1. Patients with serious primary diseases such as cardiovascular and cerebrovascular diseases, renal diseases, hematopoietic diseases, malignant tumors, and other serious complications or mental diseases;
•2. Patients with type 1 diabetes or uncontrolled type 2 diabetes, defined as HbA1c>=9.5%, or adjustment of anti-diabetes drugs in recent two months before enrollment, or history of severe hypoglycemia;
•3. Severe hepatic injury, defined as ALT>=3 ULN;
•4. Severe renal injury, defined as Scr>=178umol/L or eGFR<60;
•5. Combined with thyroid diseases, including hyperthyroidism, hypothyroidism, sub-clinical hypothyroidism;
•6. Suggestive existence of cirrhosis or hepatic function decompensation;
•7. Known allergic to the components of the research product;
•8. Pregnant and lactating women, and those who refused to maintain the contraceptive methods approved by the researchers throughout the study;
•9. Participation in other clinical trials in recent 3 months;
•10. Cannot follow the researcher's instructions for lifestyle intervention
•11. History of drug abuse or other conditions.

Sponsor

onghua Hospital, Shanghai University of Traditional Chinese Medicine