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Clinical trial

The Use of L-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis Patients

ID
Name
L-carnitine in RA
Description
This study aims at evaluating the possible efficacy and safety of L-carnitine in rheumatoid arthritis via targeting Jak/STAT pathway and TGF-β1
Trial arms
Trial start
2023-03-05
Estimated PCD
2025-03-05
Trial end
2026-03-05
Status
Recruiting
Phase
Early phase I
Treatment
L-carnitine
One 500 mg tablet twice daily after meals
Arms:
L-carnitine group
Size
46
Primary endpoint
The change in DAS-28-CRP score
3 months
The change in Multidimensional Health Assessment Questionnaire (MDHAQ) score
3 months
Eligibility criteria
Inclusion Criteria: * 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. * Patients receive the conventional DMARDs * Both sexes. * Age range between 18 and 70 years old. Exclusion Criteria: * Patients with heart disease (congestive heart failure, arrhythmia, hypertension, ischemic heart diseases), diabetes, active infection, other illness except rheumatoid arthritis. * Patients with renal and hepatic dysfunction. * Patients receiving biological DMARDs. * Patients receiving oral prednisolone greater than 15 mg/day. * Patients with hypersensitivity to study medications. * Patients using antioxidants. * Pregnant and lactating females.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 46, 'type': 'ESTIMATED'}}
Updated at
2023-03-31

1 organization

1 product

1 indication

Organization
Tanta University
Product
L-carnitine
Indication
Rheumatoid Arthritis