Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT06277635
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT06277635
Study Brief:
Protocol Section:
NCT06277635