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The Effect of Nicorandil on Rheumatoid Arthritis Patients

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllAin Shams University
NCT07730723 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

The aim of this clinical trial is to determine whether nicorandil works in minimizing disease severity in patients with rheumatoid arthritis. The study will also assess the safety and tolerability of nicorandil. The main questions it aims to answer are: * Could nicorandil improve disease severity and symptoms of rheumatoid arthritis? * Does nicorandil lower the number of times participants need to use pain relieve medications? * Does the nicorandil improve participants functionality and ability to carry out daily activity? * Does nicorandil correct disease-associated damage and inflammation? * What side effects do participants have when taking nicorandil? Researchers will compare nicorandil to a placebo (a look-alike substance that contains no drug) to see if nicorandil works to decrease symptoms and severity of rheumatoid arthritis. Participants will: * Take nicorandil or a placebo t

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adult (โ‰ฅ18 years). * Confirmed diagnosis with RA according to ACR/EULAR 2010 criteria. * Moderate to severe disease activity (DAS-28 หƒ 3.2). * Stable on conventional treatment for at least 3 months. * Adequate kidney and liver function. Exclusion Criteria: * Other autoimmune diseases * Poor patient compliance * Malignancy or history of malignancy * Pregnancy or lactation. * Patients receiving bDMARDs or tsDMARDs. * Hypersensitivity to nicorandil. * Left ventricular heart failure or severe hypotension (SBP ห‚100 mmHg). * History of cardiogenic shock. * History or active gastric ulcer. * Use of drugs contraindicated with nicorandil (e.g., sildenafil, tadalafil, vardenafil, tricyclic antidepressants, or guanyl cyclase).
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What it tests

  • Nicorandil Oral Tablet
  • Placebo
  • conventional synthetic antirheumatic drugs (cDMARDs)
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Where

1 site
Ain Shams University Hospitals
Cairo, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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