Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT05792527
Status:
RECRUITING
Last Update Posted:
2023-03-31
First Post:
2023-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
L-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002331', 'term': 'Carnitine'}], 'ancestors': [{'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2026-03-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-30', 'studyFirstSubmitDate': '2023-03-19', 'studyFirstSubmitQcDate': '2023-03-30', 'lastUpdatePostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in DAS-28-CRP score', 'timeFrame': '3 months', 'description': 'Patients will undergo clinical assessment according to DAS-28-CRP score'}, {'measure': 'The change in Multidimensional Health Assessment Questionnaire (MDHAQ) score', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'The change in serum level of C-reactive protein (CRP)', 'timeFrame': '3 months', 'description': 'Blood samples will be collected at base line and after 3 months'}, {'measure': 'The change in serum level of Signal transducer and activator of transcription 3(STAT 3).', 'timeFrame': '3 months', 'description': 'Blood samples will be collected at base line and after 3 months'}, {'measure': 'The change in serum level of Transforming growth factor β1(TGF-β1).', 'timeFrame': '3 months', 'description': 'Blood samples will be collected at base line and after 3 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This study aims at evaluating the possible efficacy and safety of L-carnitine in rheumatoid arthritis via targeting Jak/STAT pathway and TGF-β1'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with active rheumatoid arthritis (not in remission) according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 criteria (9) i.e., 28 joints disease activity score (DAS-28) \\>2.6.\n* Patients receive the conventional DMARDs\n* Both sexes.\n* Age range between 18 and 70 years old.\n\nExclusion Criteria:\n\n* Patients with heart disease (congestive heart failure, arrhythmia, hypertension, ischemic heart diseases), diabetes, active infection, other illness except rheumatoid arthritis.\n* Patients with renal and hepatic dysfunction.\n* Patients receiving biological DMARDs.\n* Patients receiving oral prednisolone greater than 15 mg/day.\n* Patients with hypersensitivity to study medications.\n* Patients using antioxidants.\n* Pregnant and lactating females.'}, 'identificationModule': {'nctId': 'NCT05792527', 'briefTitle': 'L-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'The Use of L-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis Patients', 'orgStudyIdInfo': {'id': 'L-carnitine in RA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'this group will include 23 patients which will receive the traditional therapy of RA for 3 months.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'L-carnitine group', 'description': 'this group will include 23 patients which will receive 500mg L-carnitine two times daily after meal plus the traditional therapy of RA for 3 months.', 'interventionNames': ['Drug: L-carnitine']}], 'interventions': [{'name': 'L-carnitine', 'type': 'DRUG', 'description': 'One 500 mg tablet twice daily after meals', 'armGroupLabels': ['L-carnitine group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'state': 'Gharbia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Abdallah A Eldisouky', 'role': 'CONTACT', 'email': 'PG_165476@pharm.tanta.edu.eg', 'phone': '201279142631'}], 'facility': 'Tanta university', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Abdallah A Eldisouky', 'role': 'CONTACT', 'email': 'PG_165476@pharm.tanta.edu.eg', 'phone': '201279142631'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Abdallah Abo-Elazm Shebl Eldisouky', 'investigatorAffiliation': 'Tanta University'}}}}