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Recruiting NCT07516769

Nicorandil as Anti-inflammatory in Rheumatoid Arthritis

Phase III Interventional Rhumatoid Arthisis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nicorandil 5 MG Oral Tablet.
Who it may be relevant to
Registry conditions: Rhumatoid Arthisis. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug Nicorandil 5 MG Oral Tablet
    Nicorandil 5 MG Oral Tablet

Primary outcome measures

  • change in 28-joint count Disease Activity Score (DAS28) using C- reactive protein level (CRP) [Time frame: 3 months]
  • change in Multidimensional Health Assessment Questionnaire (MDHAQ) scores. [Time frame: 3 months]
Secondary outcome measures (3)
  • The change in the serum level of 8-hydroxydeoxyguanosine (8-OHdG) at baseline and after 3 months. [Time frame: 3 months]
  • The change in the serum level of Interleukin 6 (IL-6) at baseline and after 3 months . [Time frame: 3 months]
  • The change in the serum level of C- reactive protein (CRP) at baseline and after 3 months. [Time frame: 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Tanta university — Tanta

Identifiers

NCT: NCT07516769 · Nicorandil in RA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗