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NCT Number: NCT07516769

Nicorandil as Anti-inflammatory in Rheumatoid Arthritis

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

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Key information

Conditions

Rhumatoid Arthisis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tanta university

Tanta, Gharbia Governorate, Egypt

Location status: Recruiting

Location contact

Karim Abu elfath Hussein

CONTACT

[email protected]

+201141332986

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nicorandil 5 MG Oral Tablet

Drug

Nicorandil 5 MG Oral Tablet

Primary outcomes

  1. change in 28-joint count Disease Activity Score (DAS28) using C- reactive protein level (CRP)

    Time frame: 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

  2. change in Multidimensional Health Assessment Questionnaire (MDHAQ) scores.

    Time frame: 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

Secondary outcomes

  1. The change in the serum level of 8-hydroxydeoxyguanosine (8-OHdG) at baseline and after 3 months.

    Time frame: 3 months

    Blood samples will be collected at baseline and after 3 months

  2. The change in the serum level of Interleukin 6 (IL-6) at baseline and after 3 months .

    Time frame: 3 months

    Blood samples will be collected at baseline and after 3 months

  3. The change in the serum level of C- reactive protein (CRP) at baseline and after 3 months.

    Time frame: 3 months

    Blood samples will be collected at baseline and after 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Karim Abu Elfath Hussein

CONTACT

[email protected]

+201141332986

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Clinical Study Evaluating the Effect of Nicorandil as Anti-inflammatory and Immune Modulatory in Patients With Rheumatoid Arthritis

Acronym: RA

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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