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

Early Phase 1

• Conditions: metabolic-dysfunction-associated fatty liver disease

• Registration Number: ITMCTR2024000161
• Lead Sponsor: Xiyuan Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The liver B ultrasonic sound attenuation coefficient;

Secondary Outcome Measures

Name	Time	Method
Glutamic oxalacetic transaminase;Total protein;C-reactive protein;triglyceride;Blood glucose;Direct bilirubin;Low density lipoprotein cholesterol;TCM symptom score;Insulin resistance index;glutamyltranspeptidase;Total bilirubin;Fasting plasma total cholesterol;albumin;insulin;Glutamic-pyruvic transaminase;Glycosylated hemoglobin;waistline;Tumor necrosis factor;Body mass index;High density lipoprotein cholesterol;