L-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis

Study Overview
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Brief Summary
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This study aims at evaluating the possible efficacy and safety of L-carnitine in rheumatoid arthritis via targeting Jak/STAT pathway and TGF-β1

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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: L-carnitine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>this group will include 23 patients which will receive the traditional therapy of RA for 3 months. | |
| Active Comparator: L-carnitine group<br>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. | Drug: L-carnitine<br>* One 500 mg tablet twice daily after meals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in DAS-28-CRP score | Patients will undergo clinical assessment according to DAS-28-CRP score | 3 months | 
| The change in Multidimensional Health Assessment Questionnaire (MDHAQ) score |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in serum level of C-reactive protein (CRP) | Blood samples will be collected at base line and after 3 months | 3 months | 
| The change in serum level of Signal transducer and activator of transcription 3(STAT 3). | Blood samples will be collected at base line and after 3 months | 3 months | 
| The change in serum level of Transforming growth factor β1(TGF-β1). | Blood samples will be collected at base line and after 3 months | 3 months |