Effect of Silymarin in Rheumatoid Arthritis Patients Treated With Methotrexate

Summary

The goal of this clinical trial is to evaluate the anti-rheumatic activity and the role of silymarin in attenuating methotrexate toxicity in patients with rheumatoid arthritis. Methodology: This is a randomized, double blind placebo controlled parallel study that will be conducted on 44 patients with active rheumatoid arthritis. Group1 (placebo group; n=22) which will receive IM or SC Methotrexate plus placebo tablet once daily for 3 months. Group2 (Silymarin group; n=22) which will receive IM or SC Methotrexate plus Silymarin tablets 140 mg once daily for 3 months. Duration: 3 months Monitoring: Participants will be followed up by weekly telephone calls and monthly direct meeting at scheduled visits to assess their adherence and to report any drug related adverse effects. In summary, this clinical trial is designed to determine if Silymarin is a safe and effective treatment for Rheumatoid Arthritis Patients Treated with Methotrexate by comparing its effects to a placebo and closely monitoring participants throughout the study.

Timeline

Start

2024-12-10

Primary completion

2025-03-10

Completion

2025-04-10

Publications

• Results Hagag AA, Elgamsy MA, El-Asy HM, Mabrouk MM. Protective Role of Silymarin on Hepatic and Renal Toxicity Induced by MTX Based Chemotherapy in Children with Acute Lymphoblastic Leukemia. Mediterr J Hematol Infect Dis. 2016 Sep 1;8(1):e2016043. doi: 10.4084/MJHID.2016.043. eCollection 2016.
• Results Weinblatt ME, Coblyn JS, Fox DA, Fraser PA, Holdsworth DE, Glass DN, Trentham DE. Efficacy of low-dose methotrexate in rheumatoid arthritis. N Engl J Med. 1985 Mar 28;312(13):818-22. doi: 10.1056/NEJM198503283121303.
• Results Xie Y, Feng SL, Mai CT, Zheng YF, Wang H, Liu ZQ, Zhou H, Liu L. Suppression of up-regulated LXRalpha by silybin ameliorates experimental rheumatoid arthritis and abnormal lipid metabolism. Phytomedicine. 2021 Jan;80:153339. doi: 10.1016/j.phymed.2020.153339. Epub 2020 Sep 19.
• Results Karimi G, Vahabzadeh M, Lari P, Rashedinia M, Moshiri M. "Silymarin", a promising pharmacological agent for treatment of diseases. Iran J Basic Med Sci. 2011 Jul;14(4):308-17.
• Results Nurmohamed MT, Dijkmans BA. Dyslipidaemia, statins and rheumatoid arthritis. Ann Rheum Dis. 2009 Apr;68(4):453-5. doi: 10.1136/ard.2008.104497. No abstract available.
• Results Soulaidopoulos S, Nikiphorou E, Dimitroulas T, Kitas GD. The Role of Statins in Disease Modification and Cardiovascular Risk in Rheumatoid Arthritis. Front Med (Lausanne). 2018 Feb 8;5:24. doi: 10.3389/fmed.2018.00024. eCollection 2018.
• Results Das S, Mohanty M, Padhan P. Outcome of rheumatoid arthritis following adjunct statin therapy. Indian J Pharmacol. 2015 Nov-Dec;47(6):605-9. doi: 10.4103/0253-7613.169585.
• Results Kerekes G, Nurmohamed MT, Gonzalez-Gay MA, Seres I, Paragh G, Kardos Z, Barath Z, Tamasi L, Soltesz P, Szekanecz Z. Rheumatoid arthritis and metabolic syndrome. Nat Rev Rheumatol. 2014 Nov;10(11):691-6. doi: 10.1038/nrrheum.2014.121. Epub 2014 Aug 5.
• Results Giles JT, Allison M, Blumenthal RS, Post W, Gelber AC, Petri M, Tracy R, Szklo M, Bathon JM. Abdominal adiposity in rheumatoid arthritis: association with cardiometabolic risk factors and disease characteristics. Arthritis Rheum. 2010 Nov;62(11):3173-82. doi: 10.1002/art.27629.
• Results Erum U, Ahsan T, Khowaja D. Lipid abnormalities in patients with Rheumatoid Arthritis. Pak J Med Sci. 2017 Jan-Feb;33(1):227-230. doi: 10.12669/pjms.331.11699.
• Results Amezaga Urruela M, Suarez-Almazor ME. Lipid paradox in rheumatoid arthritis: changes with rheumatoid arthritis therapies. Curr Rheumatol Rep. 2012 Oct;14(5):428-37. doi: 10.1007/s11926-012-0269-z.
• Results Roubenoff R, Roubenoff RA, Cannon JG, Kehayias JJ, Zhuang H, Dawson-Hughes B, Dinarello CA, Rosenberg IH. Rheumatoid cachexia: cytokine-driven hypermetabolism accompanying reduced body cell mass in chronic inflammation. J Clin Invest. 1994 Jun;93(6):2379-86. doi: 10.1172/JCI117244.
• Results Guo Q, Wang Y, Xu D, Nossent J, Pavlos NJ, Xu J. Rheumatoid arthritis: pathological mechanisms and modern pharmacologic therapies. Bone Res. 2018 Apr 27;6:15. doi: 10.1038/s41413-018-0016-9. eCollection 2018.
• Results McInnes IB, Schett G. The pathogenesis of rheumatoid arthritis. N Engl J Med. 2011 Dec 8;365(23):2205-19. doi: 10.1056/NEJMra1004965. No abstract available.

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