Nicorandil as Anti-inflammatory in Rheumatoid Arthritis

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07516769

Acronym

Enrollment

Registered

2026-04-08

Start date

2024-11-01

Completion date

2027-04-01

Last updated

2026-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhumatoid Arthisis

Keywords

Rhumatoid Arthisis, Nicorandil

Brief summary

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

Interventions

DRUGNicorandil 5 MG Oral Tablet

Nicorandil 5 MG Oral Tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Secondary

Measure	Time frame	Description
The change in the serum level of 8-hydroxydeoxyguanosine (8-OHdG) at baseline and after 3 months.	3 months	Blood samples will be collected at baseline and after 3 months
The change in the serum level of Interleukin 6 (IL-6) at baseline and after 3 months .	3 months	Blood samples will be collected at baseline and after 3 months
The change in the serum level of C- reactive protein (CRP) at baseline and after 3 months.	3 months	Blood samples will be collected at baseline and after 3 months

Countries

Egypt

Contacts

CONTACTKarim Abu Elfath Hussein

Kareem_hussein@pharm.tanta.edu.eg+201141332986

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 19, 2026