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Diacerein in the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease

NCT07199933 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-09-30

No results posted yet for this study

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.

Conditions

  • MAFLD

Interventions

DRUG

Diacerein 50 mg Capsule

Drug:Diacerein 50 mg Capsule. Weeks 1-4: 50 mg/day; Weeks 5-24: 100 mg/day.

DRUG

Placebo 50 mg

Drug:Placebo 50 mg Capsule. Weeks 1-4: 50 mg/day; Weeks 5-24: 100 mg/day.

Sponsors & Collaborators

  • Hongyan Wu

    lead OTHER

Principal Investigators

  • Yingjie Chen · Affiliated Hospital of Nanjing University of Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-10-31
Completion
2027-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07199933 on ClinicalTrials.gov