NCT06724952Not yet recruitingPhase 4
Effect of Silymarin in Rheumatoid Arthritis Patients Treated With Methotrexate
Clinical Study Evaluating Anti Rheumatic Activity and The Role of Silymarin in Attenuating Methotrexate Toxicity in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov · Last updated 9 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 6 Oct 2024
- Start date
- 10 Dec 2024
- Primary completion date
- 10 Mar 2025
- Lead sponsor
- Tanta University
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT06724952
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 44
- From 10 Dec 2024 to the primary completion date, 10 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Outpatient Clinic of Internal Medicine, Rheumatology and Immunology Department, Mansoura University Hospital, Mansoura, 35511 Coordinator of this site? Confirm its status | Al Mansurah | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.