Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-25 @ 3:07 AM
NCT ID:
NCT07199933
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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%.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07199933
Study Brief:
Protocol Section:
NCT07199933