L-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis

Tanta University

Status and phase: Enrolling; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: L-carnitine

Study type: Interventional

Funder types: Other

Identifiers

NCT05792527

L-carnitine in RA

Details and patient eligibility

About

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

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

46 participants in 2 patient groups

control group

No Intervention group

Description:

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

L-carnitine group

Active Comparator 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.

Treatment:

Drug: L-carnitine