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RECRUITING Phase 2 / Phase 3 ClinicalTrials.gov

The Effect of Nicorandil on Rheumatoid Arthritis Patients

Sponsor: Ain Shams University • ClinicalTrials.gov ID: NCT07730723

Registry updated: 2026-09-16
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Description

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 two times daily for 3 months * Visit the clinic once every month for checkups * Keep a diary of their symptoms and the number of times they use a pain reliever

Interventions

  • Nicorandil Oral Tablet (Drug)
    Nicorandil 10 mg oral tablets will be taken as one tablet twice daily for 3 months (12 weeks).
  • Placebo (Drug)
    Placebo oral tablets will be taken as one tablet twice daily for 3 months (12 weeks).
  • conventional synthetic antirheumatic drugs (cDMARDs) (Drug)
    A single or combination of cDMARDs and dose depend on disease severity.

Eligibility criteria

Inclusion Criteria: * Adult (≥18 years). * Confirmed diagnosis with RA according to ACR/EULAR 2010 criteria. * Moderate to severe disease activity (DAS-28 ˃ 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 ˂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).

Conditions

Rheumatoid Arthritis (RA)

Locations

  • Ain Shams University Hospitals — Cairo, Abbasia, Egypt
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record