Effect of Silymarin in Rheumatoid Arthritis Patients Treated With Methotrexate

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.

NCT Number	NCT06724952
Lead Sponsor	Tanta University
Conditions	Rheumatoid Arthritis (RA)
Enrollment	44 participants
Start Date	2024-12-10
Primary Completion	2025-03-10 (estimated)
Study Completion	2025-04-10 (estimated)
Updated on ClinicalTrials.gov	2024-12-09