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Clinical Trials/ITMCTR2024000161
ITMCTR2024000161Not yet recruitingPhase 1

Randomized double-blind placebo-controlled clinical trial of Jiangtang Xiaozhi decoction for the management of metabolic-associated fatty liver disease

Xiyuan Hospital, China Academy of Chinese Medical Sciences0 sitesStarted: TBDLast updated:
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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