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Clinical Trials in Egypt / NCT07516769
Recruiting Phase 3

Nicorandil as Anti-inflammatory in Rheumatoid Arthritis

NCT07516769 · tracked via the Priya Life Science Egypt tracker
Sponsor
Tanta University
Phase
Phase 3
Started
2024-11-01
Last updated
2026-06-18

Condition(s) studied

Rhumatoid Arthisis

Investigational drug(s) / intervention(s)

Nicorandil 5 MG Oral Tablet →

Nicorandil 5 MG Oral Tablet: Nicorandil 5 MG Oral Tablet

Study summary

This study aims to evaluate the possible efficacy and safety of nicorandil as anti-inflammatory in managing patients with active rheumatoid arthritis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Patients with active rheumatoid arthritis (not in remission) according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) i.e., 28 joints disease activity score (DAS-28) \>2.6. * Patients receiving the conventional DMARDs Exclusion Criteria: * Patients with heart disease (congestive heart failure, arrhythmia and ischemic heart disease), diabetes, active infection, and other illness except rheumatoid arthritis. * Patients with severe renal and hepatic dysfunction. - Patients receiving biological DMARDs. * Patients receiving oral prednisolone greater than 15mg/day. * Patients with hypersensitivity to study medications. * Patients using antioxidants. * Pregnant and lactating females.

Primary outcome measure(s)

  • change in 28-joint count Disease Activity Score (DAS28) using C- reactive protein level (CRP) — 3 months
    Calculation of 28-joint count Disease Activity Score (DAS28) using C- reactive protein level (CRP) where: Remission: \< 2.6. Low Disease Activity (LDA): ≤ 3.2. Moderate Disease Activity (MDA): 3.2 - 5.1. High Disease Activity (HDA): \> 5.1
  • change in Multidimensional Health Assessment Questionnaire (MDHAQ) scores. — 3 months
    Before and 3 months after the intervention, the validated Arabic Multidimensional Health Assessment Questionnaire (MDHAQ) Physical Function: Assessed through 10 activities, scored 0-3 (without difficulty=0, some=1, much=2, unable=3), with higher scores indicating worse function

Trial sites (1)

FacilityCityRegionStatus
Tanta university Tanta Gharbia Governorate Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07516769 on ClinicalTrials.gov ↗ ← All trials in Egypt