Effect of Silymarin Against Methotrexate-induced Liver Injury in Rheumatic Diseases, a Double-blind Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

To study the effect of silymarin against methotrexate-induced liver injury in rheumatic diseases including rheumatoid arthritis, psoriatric arthritis and psoriasis

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• Aged \> 20 years

• Diagnosis at least one of the following

‣ Rheumatoid arthritis according to American College of Rheumatology/ The European Alliance of Associations for Rheumatology 2010(ACR/EULAR2010) with at least one joint swelling or tenderness or

⁃ Psoriatric arthritis according to CASPAR classification criteria with at least one joint swelling or tenderness, or at least one site dactylitis or enthesitis or Psoriasis by dermatologist with active skin lesion

⁃ No previous treatment with methotrexate or treatment with methotrexate within 30 day before randomization

⁃ No previous treatment with other conventional synthetic DMARDs other than methotrexate such as sulfasalazine, hydroxycholoquine, leflunomide

⁃ No previous treatment with biologic DMARDs such as anti-TNF

⁃ Can follow the treatment protocal

Locations
Other Locations
Thailand
Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine
RECRUITING
Bangkok, Thailand, 10400
Contact Information
Primary
Rattapol Pakchotanon, M.D.
rattapolpmk@gmail.com
66+2 354 7980
Backup
Chatpong Makmee, M.D.
chatpongmakmee17@gmail.com
0862204693
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2025-04
Participants
Target number of participants: 72
Treatments
Active_comparator: Silymarin group
Silymarin 140 mg oral tid pc + methotrexate weekly + folic acid 5 mg oral OD pc for 12 weeks
Placebo_comparator: Placebo group
Placebo + methotrexate weekly + folic acid 5 mg oral OD pc for 12 weeks
Sponsors
Leads: Phramongkutklao College of Medicine and Hospital

This content was sourced from clinicaltrials.gov