The Effect of Nicorandil on Rheumatoid Arthritis Patients

Summary

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

Timeline

Start

2026-09-06

Primary completion

2027-07

Completion

2027-07

Publications

• Background Okasha AH, Hegab II, Seleem MA, Azzam AR, Ibrahim S, Ghalwash AA, El-Gohary RM. Effects of Fisetin and Nicorandil on adjuvant-induced rheumatoid arthritis in rats: Emerging role of TLR4/NF-kappaB-induced Pyroptosis, Nrf-2/HO-1, and OPG/RANKL pathways. Cytokine. 2025 Mar;187:156876. doi: 10.1016/j.cyto.2025.156876. Epub 2025 Jan 29.
• Background Zong Y, Li J, Xu X, Xu X. Effects of nicorandil on systemic inflammation and oxidative stress induced by percutaneous coronary intervention in patients with coronary heart disease. J Int Med Res. 2021 Dec;49(12):3000605211058873. doi: 10.1177/03000605211058873.
• Background Xu S, Cao X, Yu Z, He W, Pang Y, Lin W, Chen Z, Guo W, Lu X, Lin C. Nicorandil Inhibits Osteoclast Formation Base on NF-kappaB and p-38 MAPK Signaling Pathways and Relieves Ovariectomy-Induced Bone Loss. Front Pharmacol. 2021 Sep 8;12:726361. doi: 10.3389/fphar.2021.726361. eCollection 2021.
• Background Saad MA, El-Sahhar AE, Arab HH, Al-Shorbagy MY. Nicorandil abates arthritic perturbations induced by complete Freund's adjuvant in rats via conquering TLR4-MyD88-TRAF6 signaling pathway. Life Sci. 2019 Feb 1;218:284-291. doi: 10.1016/j.lfs.2019.01.002. Epub 2019 Jan 3.
• Background Gaafar AGA, Messiha BAS, Abdelkafy AML. Nicorandil and theophylline can protect experimental rats against complete Freund's adjuvant-induced rheumatoid arthritis through modulation of JAK/STAT/RANKL signaling pathway. Eur J Pharmacol. 2018 Mar 5;822:177-185. doi: 10.1016/j.ejphar.2018.01.009. Epub 2018 Jan 11.
• Background Quinonez-Flores CM, Gonzalez-Chavez SA, Pacheco-Tena C. Hypoxia and its implications in rheumatoid arthritis. J Biomed Sci. 2016 Aug 22;23(1):62. doi: 10.1186/s12929-016-0281-0.

Drugs

Indications