ITMCTR2024000161Not yet recruitingPhase 1
Randomized double-blind placebo-controlled clinical trial of Jiangtang Xiaozhi decoction for the management of metabolic-associated fatty liver disease
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65 (—)
- Sex
- All
Inclusion Criteria
- •(1) in line with the western medicine diagnostic criteria, MAFLD liver ultrasound conforms to the imaging diagnosis of fatty liver, and the standard of syndromes of traditional Chinese medicine;
- •(2) age between 18-65 years old;
- •(3) the subjects were informed, voluntary signing informed consent;
- •(4) the blood sugar level: a1c < 8.5%, FBG < 10 tendency for l, PBG < 13 tendency for l.
Exclusion Criteria
- •(1) obviously abnormal liver function (ALT and AST > upper limit of normal) for more than 2 times; Adding other liver-protecting, enzyme reducing drugs or health care products in the past month to affect the efficacy evaluation;
- •(2) of liver fibrosis, liver cirrhosis, liver solid tumors, and the regenerative nodules of focal fatty liver can't rule out or turn move tumor; Can lead to other liver fatty liver disease, Autoimmune liver disease, Autoimmune liver diseases), drug-induced liver injury (DILI), etc.;
- •(3) patients treated with GLP-1,SGLT-2 and TZD drugs;
- •(4) within 3 months before randomization use a steady dose of statins or Betty drugs;
- •(5) Acute complications of diabetes in the past three months;
- •(6) patients with serious organic diseases of the heart, lung, kidney or other important organs or serious diseases of the hematopoietic system, tumors, serious cardiovascular and cerebrovascular diseases, or mental disorders;
- •(7) abnormal renal function;
- •(8) pregnancy or ready to pregnant women, nursing mothers.
- •This study drug allergy (9);
- •(10) unable to perform the examinations and tests involved in this study;
- •(11) can't cooperation or is in any other clinical subjects.
Investigators
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