Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT06277635
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Silymarin Against Methotrexate-induced Liver Injury in Rheumatic Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012838', 'term': 'Silymarin'}, {'id': 'C000713827', 'term': 'milk-thistle extract'}], 'ancestors': [{'id': 'D044947', 'term': 'Flavonolignans'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-22', 'studyFirstSubmitDate': '2024-02-12', 'studyFirstSubmitQcDate': '2024-02-22', 'lastUpdatePostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AST or ALT > 1X ULN ( normal AST and ALT 0-50 U/L)', 'timeFrame': '12 weeks', 'description': 'elevation of AST or ALT more than 1X ULN (% participant)'}], 'secondaryOutcomes': [{'measure': 'AST or ALT > 2X ULN ( normal AST and ALT 0-50 U/L) AST or ALT > 2X ULN AST or ALT > 2X ULN', 'timeFrame': '12 weeks', 'description': 'elevation of AST or ALT more than 2X ULN (% participant)'}, {'measure': 'AST or ALT > 3X ULN ( normal AST and ALT 0-50 U/L)', 'timeFrame': '12 weeks', 'description': 'elevation of AST or ALT more than 3X ULN (% participant)'}, {'measure': 'AST or ALT > 5X ULN or >3X ULN ( normal AST and ALT 0-50 U/L) with symptom of hepatitis such as Fatique, abdominal pain, nausea, vomiting or total bilirubin > 2X with jaundice', 'timeFrame': '12 weeks', 'description': 'elevation of AST or ALT \\> 5X ULN or \\>3X ULN with symptom of hepatitis such as Fatique, abdominal pain, nausea, vomiting or total bilirubin \\> 2X with jaundice (% participant)'}, {'measure': 'Discontinuation rate of methotrexate', 'timeFrame': '12 weeks', 'description': 'Rate of methotrexate discontinuation (%)'}, {'measure': 'Adverse events', 'timeFrame': '12 weeks', 'description': 'Rate of any adverse events (%)'}, {'measure': 'Change of DAS-28 ESR or CRP Score', 'timeFrame': '12 weeks', 'description': 'Change of DAS-28 ESR or CRP Score for patients with Rheumatoid arthritis and psoriatric arthritis (unit)'}, {'measure': 'Change of BASDAI Score', 'timeFrame': '12 weeks', 'description': 'Change of BASDAI Score for AS (unit)'}, {'measure': 'Change of ASDAS ESR or CRP Score', 'timeFrame': '12 weeks', 'description': 'Change of ASDAS ESR or CRP Score for AS (unit)'}, {'measure': 'Change of BSA for psoriasis', 'timeFrame': '12 weeks', 'description': 'Change of BSA for psoriasis (unit)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rheumatoid arthritis', 'Psoriatric arthritis', 'Psoriasis', 'Methotrexate', 'Silymarin'], 'conditions': ['Rheumatoid Arthritis', 'Psoriatic Arthritis', 'Psoriasis']}, 'descriptionModule': {'briefSummary': 'To study the effect of silymarin against methotrexate-induced liver injury in rheumatic diseases including rheumatoid arthritis, psoriatric arthritis and psoriasis', 'detailedDescription': '\\- 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%'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged \\> 20 years\n* Diagnosis at least one of the following\n\n 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\n 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\n 3. No previous treatment with methotrexate or treatment with methotrexate within 30 day before randomization\n 4. No previous treatment with other conventional synthetic DMARDs other than methotrexate such as sulfasalazine, hydroxycholoquine, leflunomide\n 5. No previous treatment with biologic DMARDs such as anti-TNF\n 6. Can follow the treatment protocal\n\nExclusion Criteria:\n\n* Pregnancy or planning for pregnancy\n* Breastfeeding women\n* Ongoing treatment with active malignancy\n* GFR \\< 30 ml/min/1.73m2\n* Previous documented of HIV infection\n* Chronic alcohol drinking ≥ 3 times/wk or drug abuse within 6 months prior to randomization\n* Positive of HbsAg, anti HCV\n* Previous documented of preexisting liver disease such as alcoholic liver disease, liver cirrhosis, autoimmune hepatitis\n* AST or ALT \\> ULN ( 0-50 U/L )\n* WBC \\< 3,000/ul or platelet \\< 100,000 /ul, ANC \\< 1,500/ul\n* ILD diagnosed by rheumatologist and pulmonologist from chest X ray and HRCT\n* 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\n* Cannot follow up on treatment protocal'}, 'identificationModule': {'nctId': 'NCT06277635', 'briefTitle': 'Effect of Silymarin Against Methotrexate-induced Liver Injury in Rheumatic Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Phramongkutklao College of Medicine and Hospital'}, 'officialTitle': 'Effect of Silymarin Against Methotrexate-induced Liver Injury in Rheumatic Diseases, a Double-blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'TAPAC001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Silymarin group', 'description': 'Silymarin 140 mg oral tid pc + methotrexate weekly + folic acid 5 mg oral OD pc for 12 weeks', 'interventionNames': ['Drug: Silymarin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo + methotrexate weekly + folic acid 5 mg oral OD pc for 12 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Silymarin', 'type': 'DRUG', 'otherNames': ['Milk Thistle'], 'description': 'Silymarin is randomly assigned to the participants for 12 weeks during study.', 'armGroupLabels': ['Silymarin group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo is randomly assigned to the participants for 12 weeks during study.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok, Thailand, 10400', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Rattapol Pakchotanon, M.D.', 'role': 'CONTACT', 'email': 'rattapolpmk@gmail.com', 'phone': '66+23547980'}, {'name': 'Rattapol Pakchotanon, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Supasa Niyompanichakarn, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Rattapol Pakchotanon, M.D.', 'role': 'CONTACT', 'email': 'rattapolpmk@gmail.com', 'phone': '66+2 354 7980'}, {'name': 'Chatpong Makmee, M.D.', 'role': 'CONTACT', 'email': 'chatpongmakmee17@gmail.com', 'phone': '0862204693'}], 'overallOfficials': [{'name': 'Rattapol Pakchotanon, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Phramongkutklao College of Medicine and Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'mid 2026', 'ipdSharing': 'YES', 'description': 'Study Protocol is to be shared with others. Full data would become available by mid 2026.', 'accessCriteria': 'IPD Sharing Access Criteria has not been decided.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Phramongkutklao College of Medicine and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}