L-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis

Phase 3

Recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: L-carnitine

• Registration Number: NCT05792527
• Lead Sponsor: Tanta University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study Start: 2023-03-05
• Study First Submitted: 2023-03-19
• Study First Submitted QC: 2023-03-30
• Last Update Submitted: 2023-03-30
• Study First Posted: 2023-03-31
• Last Update Posted: 2023-03-31
• Primary Completion: 2025-03-05
• Study Completion: 2026-03-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-carnitine group	L-carnitine	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.

Primary Outcome Measures

Name	Time	Method
The change in DAS-28-CRP score	3 months	Patients will undergo clinical assessment according to DAS-28-CRP score
The change in Multidimensional Health Assessment Questionnaire (MDHAQ) score	3 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tanta university; 🇪🇬 Tanta, Gharbia, Egypt