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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000161
Enrollment
Unknown
Registered
2024-08-04
Start date
2024-08-20
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metabolic-dysfunction-associated fatty liver disease

Interventions

Experimental Group:Oral Jiangtang Xiaozhi prescription was given 2 times a day, 1 bag each time, for 12 weeks
Control group:Oral placebos, 2 times a day, 1 bag each time, after 12 weeks of treatment

Sponsors

Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The liver B ultrasonic sound attenuation coefficient;

Secondary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactChen Zhuhong

Xiyuan Hospital, China Academy of Chinese Medical Sciences

13264214919@163.com13264214919

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026