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Clinical Trials in Egypt / NCT06753565
Recruiting Phase 2

L-carnitine Supplementation in Rheumatoid Arthritis Patients

NCT06753565 · tracked via the Priya Life Science Egypt tracker
Sponsor
German University in Cairo
Phase
Phase 2
Started
2024-12-31
Last updated
2025-01-07

Condition(s) studied

Rheumatoid Arthritis (RA)

Investigational drug(s) / intervention(s)

Carnitine →Disease-modifying anti-rheumatic drugs

Carnitine: It is a nutritional supplement with trade name " Carnitol®" in Egypt.

Disease-modifying anti-rheumatic drugs: They are immunosuppressive drugs used to improve disease activity in Rheumatoid Arthritis patients . Conventional DMARDs include methotrexate (Imutrexate®) , leflunomide(Arthfree®) , hydroxychloroquine (plaquenil®) and sulfasalazine(colosalazine®) .

Study summary

This study aims to evaluate the effect of l-carnitine as add- on therapy for improving the outcome in rheumatoid arthritis patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: * age between 18-60 years old * diagnosed of rheumatoid arthritis according to 2010 American College of Rheumatology/European League Against Rheumatism criteria for at least 6 months * enrolled patients treated with one of more of conventional DMARDs for ≥ 6 months with stable dose for ≥ 1 month before start of the study * active RA despite conventional DMARDs treatment (DAS28 ESR more than or equal 3.2) * patient or legal representative should sign informed consent Exclusion Criteria: * pregnant or lactating female * patients with liver dysfunction (\>1.5x the upper limit of normal value for ALT \& AST) * Patients with kidney dysfunction (serum creatinine more than 1.2 mg/dl) * Patients with any active infection or concurrent malignancy * patients with uncontrolled medical conditions or other rheumatic diseases * patients currently taking drugs that could interact with carnitine like: warfarin

Primary outcome measure(s)

  • change in DAS28 ESR for both arms — From enrollment to the end of trial at 12 weeks
    DAS 28-ESR is a score used to measure disease activity in RA patients. it is calculated using an equation where number of tender joints ( out of 28 joints) , number of swollen joints ( out of 28 joints) , patient assessment of disease activity ( using visual analogue scale from zero to 10) and ESR level are used as inputs to give DAS 28-ESR as output . the score will be measured to all participants both at baseline and at end of study. Higher scores indicate higher disease activity .

Trial sites (1)

FacilityCityRegionStatus
Demerdash hospital Cairo Demerdash Recruiting

More German University in Cairo trials in Egypt

Evaluation of the Effect of L-Arginine on the Cognitive Function in Geriatric Patients Recruiting
Effect of Add-on L-Arginine Therapy on Heart Failure Patients Starting soon

Other trials for the same condition

The Possible Efficacy and Protective Effect of Empagliflozin in Rheumatoid Arthritis Patients Treated with Methotrexate Starting soon
Desloratadine as Adjunct Therapy for Rheumatoid Arthritis Recruiting
Correlation Between Circulating Fibroblast Activation Protein (FAP) and Fibrosis in Two Diseases (Rheumatoid Arthritis and Systemic Sclerosis) Starting soon
The Effect of Nicorandil on Rheumatoid Arthritis Patients Recruiting
Effect of Roflumilast as Add-On Therapy in Rheumatoid Arthritis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06753565 on ClinicalTrials.gov ↗ ← All trials in Egypt