Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07730723

The Effect of Nicorandil on Rheumatoid Arthritis Patients

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Rheumatoid Arthritis (RA) Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Inflammation Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ain Shams University

Cairo, Abbasia, 11566, Egypt

Location contact

Sondos S. saleh

CONTACT

[email protected]

About this study

Rheumatoid arthritis (RA) is a progressive systemic inflammatory autoimmune disease mainly affecting joints. Adequate treatment and control are important to prevent disease progression and extra-articular complications. Nicorandil is a nicotinamide anti-anginal drug with a potent anti-ischemic, anti-hypoxic, anti-inflammatory and immunomodulatory characteristics that may be potentially effective in the management of autoimmune diseases. Therefore, nicorandil would be a candidate intervention based on previous clinical trial on non-RA patients and animal studies on RA models.

This randomized stratified double-blinded clinical trial will recruit 70 patients based on inclusion criteria. Patients will be randomized to either receive nicorandil 10 mg twice daily or placebo twice daily in addition to conventional treatment for RA for 3 months. The study will be carried out according to ethical considerations.

Patients will be evaluated on monthly bases. At baseline patient history, demographic data, medical and medication history will be documented through patient interview and medical records. At baseline and after completion of 3 months of treatment, investigator will evaluate the patient for treatment safety and efficacy. Evaluation will include disease activity, frequency for using analgesics, quality of life, level of inflammatory mediators, and cartilage integrity. Throughout the study, patient will be followed up closely for any reported adverse effect. At the end of the study, statistical analysis will be done using SPSS software package and the appropriate test will be used.

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Nicorandil Oral Tablet

Drug

Nicorandil 10 mg oral tablets will be taken as one tablet twice daily for 3 months (12 weeks).

Other names: Randil

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.

Other names: methotrexate, leflunomide, sulfasalazine, hydroxychloroquine

Primary outcomes

  1. Evaluation of treatment Efficacy

    Time frame: At baseline and at the end of the study (3 months (12 weeks)).

    Treatment efficacy will be evaluated using disease activity score DAS-28 and the frequency of using analgesics due to arthritis pain.

    Score interpretation:

    Score <2.6 means disease remission, 2.6-3.2 means low disease activity, >3.2-5.1 means moderate disease activity, and >5.1 means high disease activity. After treatment intervention, a DAS-28 score reduction by 0.6 represents a moderate improvement, while a reduction more than 1.2 represents a major improvement.

    The frequency of using analgesics will be documented by patient using a diary sheet and weekly evaluation.

Secondary outcomes

  1. Evaluation of quality of life (QOL)

    Time frame: At baseline and at the end of the study (3 months (12 weeks)).

    Patients՚ QOL will be evaluated using the validated Arabic version of the Health Assessment Questionnaire Disability Index (HAQ-DI). The questionnaire involves eight different aspects evaluating patients' daily activities. Each aspect consists of 2 to 3 questions that are scored from 0 (without any difficulty) to 3 (unable to do). The higher the score, the poorer the QOL.

Other outcomes

  1. Evaluation of inflammation

    Time frame: At baseline and at the end of the study (3 months (12 weeks)).

    Blood samples will be collected from patients at baseline and at the end of the study after 3 months. Blood samples will be directly centrifuged and serum will be stored at -80 °C until analysis. Inflammation will be evaluated through measuring the erythrocyte sedimentation rate (ESR) and serum level of C reactive protein (CRP) using Westergren method and the Nephelometric method, respectively.

  2. Nicorandil safety assessment

    Time frame: Monthly for 3 months (12 weeks).

    All patients will be educated on how to use nicorandil and the most probable adverse effects. They will be evaluated for adverse effects and their severity on monthly visits. Patients will be informed to report any adverse effects and their severity to the investigator by phone calls and at the time of the clinical visit.

    The most commonly associated adverse effects include headache, GIT, skin or mucosal ulceration, decreased appetite, and orthostatic hypotension. As a preventive measure, blood pressure will be measured at baseline and periodically to exclude patients with significant hypotension.

Study contacts

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

Sondos S. Saleh, Assisstant Lecturer

CONTACT

[email protected]

+201153495055

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Effect of Nicorandil on Disease Activity in Rheumatoid Arthritis Patients

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2026
Registry last updated
Jul 28, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.