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Effect of Silymarin Against Methotrexate-induced Liver Injury in Rheumatic Diseases

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 20 Years and Over
Gender All
More 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06277635
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Phramongkutklao College of Medicine and Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Rattapol Pakchotanon, M.D.
Principal Investigator Affiliation Phramongkutklao College of Medicine and Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Thailand
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis
Additional Details

  • - Methotrexate was indeed a common and effective treatment for rheumatoid arthritis, psoriatic arthritis and psoriasis.
Methotrexate-related hepatotoxicity are common occur 1:1,100 persons. Liver abnormalities varies from asymptomatic liver enzyme elevation to fatal hepatic necrosis and liver fibrosis. Methotrexate was discontinued owing to liver dysfunction in 7.4%

Arms & Interventions

Arms

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

Interventions

Drug: - Silymarin

Silymarin is randomly assigned to the participants for 12 weeks during study.

Drug: - Placebo

Placebo is randomly assigned to the participants for 12 weeks during study.

Contact a Trial Team

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International Sites

Bangkok, Thailand, 10400, Bangkok, Thailand

Status

Recruiting

Address

Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine

Bangkok, Thailand, 10400, Bangkok, 10400

Site Contact

Rattapol Pakchotanon, M.D.

rattapolpmk@gmail.com

66+23547980

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