NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

The Effect of Nicorandil on Rheumatoid Arthritis Patients

Not Yet RecruitingPhase 2, Phase 3

Sponsor: Ain Shams University

Conditions: Rheumatoid Arthritis (RA)

Interventions: Nicorandil Oral Tablet, Placebo, conventional synthetic antirheumatic drugs (cDMARDs)

Countries: Egypt

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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).

Locations (1)

Cairo, Abbasia, Egypt