Status:
NOT_YET_RECRUITING
Diacerein in the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease
Lead Sponsor:
Hongyan Wu
Conditions:
MAFLD
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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...
Detailed Description
1. Rhubarb and Its Derivatives Have a Solid Theoretical Basis for Treating MAFLD Metabolic dysfunction-associated fatty liver disease (MAFLD), a chronic progressive liver disease caused by nutritional...
Eligibility Criteria
Inclusion
- Fully understand this study and voluntarily sign the informed consent form; willing to comply with and capable of completing all trial procedures.
- Meet the diagnostic criteria for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).
- Age ≥18 and ≤60 years, regardless of gender.
Exclusion
- Patients with other diseases that may secondarily cause fatty liver disease, including hepatitis B or C virus infection, α-1 antitrypsin deficiency, Wilson's disease, hemochromatosis, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, or HIV infection.
- Alcohol consumption ≥140 g/week for females or ≥210 g/week for males.
- Patients with current or history of cirrhosis or any prior event of hepatic decompensation (i.e., ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, esophageal varices, and/or hepatorenal syndrome).
- (4) Patients with abnormal vital signs, complete blood count (CBC), renal function, or thyroid function (Alanine Aminotransferase \[ALT\] \>5× upper limit of normal \[ULN\]; Creatinine \[Cr\] \>ULN; Albumin \[ALB\] \<3.5 g/L; TSH \>2× ULN; electrolyte imbalances).
- Patients with severe cardiovascular or cerebrovascular diseases (including uncontrolled hypertension, defined as systolic blood pressure \>170 mmHg or diastolic blood pressure \>100 mmHg), renal diseases, hematopoietic system diseases, psychiatric disorders, autoimmune diseases, or active cancer.
- Glycated Hemoglobin A1c (HbA1c) \>7% (in patients without prior history of diabetes).
- Patients with inflammatory bowel disease, intestinal obstruction or pseudo-obstruction, chronic diarrhea, or unexplained abdominal pain.
- Use of medications related to MASLD within 3 months prior to the study (e.g., metformin, thiazolidinediones, dipeptidyl peptidase-4 inhibitors \[DPP-4i\], glucagon-like peptide-1 receptor agonists \[GLP-1RA\], sodium-glucose cotransporter-2 inhibitors \[SGLT-2i\], S-adenosylmethionine \[SAM-e\], polyenphosphatidylcholine, glycyrrhizin, bicyclol, reduced glutathione, betaine, fish oil, silymarin, obeticholic acid/ursodeoxycholic acid \[OCA/UDCA\], phosphodiesterase inhibitors \[PDEi\], gemfibrozil, vitamin E, long-term antibiotics \[\>1 week\], THR-β agonists \[resmetirom\], initiation or adjustment of lipid-lowering regimens, corticosteroids, immunosuppressants, or Chinese herbal extracts for MASLD treatment \[e.g., hawthorn, cassia seed, salvia, notoginseng, kudzu, alisma\], or herbal teas \[e.g., Ilex chingiana, Kuding tea, Gynostemma, lotus leaf, Pu-erh tea\]). Exclusion applies if any of the above criteria are met.
- History of bariatric surgery within the past 2 years.
- History of allergy to diacerein or anthraquinone derivatives.
- Use of diacerein within the past 3 months.
- Pregnant or lactating women, or those planning pregnancy within the next 6 months.
- Participation in another clinical trial involving investigational drugs or devices.
- Contraindications to conventional MRI (e.g., metal implants).
- Inability to complete the study or comply with its requirements, as determined by the investigator.
- Weight gain or loss \>5% within 6 months prior to baseline, or \>10% within 12 months prior to screening.
- CAP value ≥248 dB/m on Fibroscan but MRI-PDFF \<5%.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT07199933
Start Date
October 1 2025
End Date
October 31 2027
Last Update
September 30 2025
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