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Diacerein in the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease
Sponsor: Hongyan Wu
Summary
Metabolic dysfunction-associated fatty liver disease (MAFLD) is the most common chronic progressive liver disease in China, posing a significant risk for hepatic decompensation, cardiovascular disease (CVD), chronic kidney disease (CKD), and various malignancies. It severely impacts patient quality of life and life expectancy, creating a substantial socioeconomic burden. Currently, no safe and effective drug exists to reverse MAFLD. Rhubarb (Dà Huáng), a classic Traditional Chinese Medicine (TCM) herb for liver disorders, has a cold nature, bitter taste, and targets the liver, spleen, stomach, large intestine, and pericardium meridians. Its primary active component, Rhein, demonstrates therapeutic potential by targeting key MAFLD pathological processes-insulin resistance, hepatic steatosis, inflammation, and fibrosis. Supporting this, a previous randomized, double-blind, placebo-controlled trial by our group on diacerein (a Rhein derivative) for simple obesity showed that it not only reduced body weight but also improved liver function, Controlled Attenuation Parameter (CAP), and Liver Stiffness Measurement (LSM). Therefore, this study will investigate diacerein-a marketed drug metabolized to Rhein in vivo-for MAFLD treatment using a randomized, double-blind, placebo-controlled design. The aim is to generate clinical evidence for diacerein and other Rhein derivatives within an integrative medicine framework, providing an evidence-based rationale for expanding the application of rhubarb in MAFLD management.
Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Diacerein in the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease in Adults
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
74
Start Date
2025-10-01
Completion Date
2027-10-31
Last Updated
2025-09-30
Healthy Volunteers
No
Conditions
Interventions
Diacerein 50 mg Capsule
Drug:Diacerein 50 mg Capsule. Weeks 1-4: 50 mg/day; Weeks 5-24: 100 mg/day.
Placebo 50 mg
Drug:Placebo 50 mg Capsule. Weeks 1-4: 50 mg/day; Weeks 5-24: 100 mg/day.