Using silymarin to protect the liver from methotrexate damage in rheumatic diseases
Effect of Silymarin Against Methotrexate-induced Liver Injury in Rheumatic Diseases, a Double-blind Randomized Controlled Trial
This study is testing if silymarin can help protect the liver from damage caused by methotrexate in people with rheumatic diseases like rheumatoid arthritis and psoriasis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Phramongkutklao College of Medicine and Hospital Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Bangkok, Thailand, 10400, Bangkok) |
| Trial ID | NCT06277635 on ClinicalTrials.gov |
What this trial studies
This study investigates the protective effects of silymarin against liver injury caused by methotrexate in patients with rheumatic diseases such as rheumatoid arthritis, psoriatic arthritis, and psoriasis. Methotrexate is a commonly used treatment for these conditions but can lead to serious liver complications. Participants will be randomly assigned to receive either silymarin or a placebo while being monitored for liver function. The goal is to determine if silymarin can reduce the incidence of liver damage associated with methotrexate treatment.
Who should consider this trial
Good fit: Ideal candidates include adults over 20 years old with a diagnosis of rheumatoid arthritis, psoriatic arthritis, or psoriasis who have not previously been treated with methotrexate.
Not a fit: Patients who are pregnant, breastfeeding, or have ongoing malignancies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer treatment option for patients requiring methotrexate for their rheumatic diseases.
How similar studies have performed: While the use of silymarin for liver protection is known, this specific application in the context of methotrexate-induced liver injury in rheumatic diseases is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged \> 20 years * Diagnosis at least one of the following 1. 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 2. 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 3. No previous treatment with methotrexate or treatment with methotrexate within 30 day before randomization 4. No previous treatment with other conventional synthetic DMARDs other than methotrexate such as sulfasalazine, hydroxycholoquine, leflunomide 5. No previous treatment with biologic DMARDs such as anti-TNF 6. Can follow the treatment protocal Exclusion Criteria: * Pregnancy or planning for pregnancy * Breastfeeding women * Ongoing treatment with active malignancy * GFR \< 30 ml/min/1.73m2 * Previous documented of HIV infection * Chronic alcohol drinking ≥ 3 times/wk or drug abuse within 6 months prior to randomization * Positive of HbsAg, anti HCV * Previous documented of preexisting liver disease such as alcoholic liver disease, liver cirrhosis, autoimmune hepatitis * AST or ALT \> ULN ( 0-50 U/L ) * WBC \< 3,000/ul or platelet \< 100,000 /ul, ANC \< 1,500/ul * ILD diagnosed by rheumatologist and pulmonologist from chest X ray and HRCT * History documented silymarin hypersensitivity or severe adverse effects diagnosed by physician or pharmacist from PMK hospital or from history drug allergy or symptoms such as rash, chest tightness, dyspnea, diarrhea and hypotension * Cannot follow up on treatment protocal
Where this trial is running
Bangkok, Thailand, 10400, Bangkok
- Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine — Bangkok, Thailand, 10400, Bangkok, Thailand (Recruiting)
Study contacts
- Study coordinator: Rattapol Pakchotanon, M.D.
- Email: rattapolpmk@gmail.com
- Phone: 66+2 354 7980
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.