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Effect of Silymarin in Rheumatoid Arthritis Patients Treated With Methotrexate
Sponsor: Tanta University
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.
Official title: Clinical Study Evaluating Anti Rheumatic Activity and The Role of Silymarin in Attenuating Methotrexate Toxicity in Patients With Rheumatoid Arthritis
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2024-12-10
Completion Date
2025-04-10
Last Updated
2024-12-09
Healthy Volunteers
No
Conditions
Interventions
MTX S.C or IM and Silymarin 140 mg tab
IM or S.C Methotrexate plus Silymarin tablets 140 mg once daily for 3 months.
MTX S.C or IM
IM or SC Methotrexate plus placebo tablet once daily for 3 months.
Locations (1)
Outpatient Clinic of Internal Medicine, Rheumatology and Immunology Department, Mansoura University Hospital, Mansoura, 35511
Al Mansurah, Egypt