Tests silymarin with methotrexate in adults with rheumatoid arthritis
Tests silymarin alongside methotrexate in adults with active rheumatoid arthritis.
Plain-language title generated from the registry record
Registry title: Effect of Silymarin in Rheumatoid Arthritis Patients Treated With Methotrexate
Key facts
- Where
- Al Mansurah, EgyptSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT06724952, who can take part
Where in Egypt
- Outpatient Clinic of Internal Medicine, Rheumatology and Immunology Department, Mansoura University Hospital, Mansoura, 35511Al Mansurah, EgyptNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tanta University
- Trial code
- NCT06724952
- Record updated
- 9 December 2024
- Original description
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.Read full original descriptionShow less
Clinical Study Evaluating Anti Rheumatic Activity and The Role of Silymarin in Attenuating Methotrexate Toxicity in Patients With Rheumatoid Arthritis
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.
Inclusion criteria:; Patients with active rheumatoid arthritis (not in remission) according to 28 joints disease activity score (DAS-28) >2.6; Age range between 18 and 60 years old; Both sexes; Sex ratio, age, disease activity, and disease duration matched patients; Patients receive methotrexate plus traditional therapy; Exclusion criteria:; Patients with renal or hepatic diseases (chronic liver disease, liver cirrhosis, alcoholic hepatitis, or chronic alcoholism); Patients receiving biological DMARDs; Patients with hypersensitivity to study medications; Patients using antioxidants except silymarin; Pregnant and lactating females.