L-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis

What Was Tested

The trial (phase 3) is built around L-Carnitine for rheumatoid arthritis.

It had two arms (groups): control group (no intervention) and L-carnitine group (active comparator).

This group will include 23 patients which will receive the traditional therapy of RA for 3 months.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 46 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Age range between 18 and 70 years old.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The rheumatoid arthritis participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.

The L-Carnitine group and the comparison group ran side by side rather than switching.

Everyone knew when L-Carnitine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2023-03-05 with completion listed for 2025-03-05.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The change in DAS-28-CRP score (time frame: 3 months). The change in Multidimensional Health Assessment Questionnaire (MDHAQ) score (time frame: 3 months).

It also tracked 3 secondary outcomes, for example The change in serum level of C-reactive protein (CRP), The change in serum level of Signal transducer and activator of transcription 3(STAT 3) and The change in serum level of Transforming growth factor β1(TGF-β1).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of L-Carnitine in 46 people with rheumatoid arthritis.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, Rheumatoid arthritis research.