L-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05792527
• Other study ID #: L-carnitine in RA
• Status: Recruiting
• Phase: Phase 3
• Start date: March 5, 2023
• Est. completion date: March 5, 2026

Study information

• Verified date: March 2023
• Source: Tanta University
• Contact: Abdallah A Eldisouky
• Phone: 201279142631
• Email: PG_165476[@]pharm.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: March 5, 2026
• Est. primary completion date: March 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Inflammation
• Rheumatoid Arthritis

Intervention

Drug:
• L-carnitine
One 500 mg tablet twice daily after meals

Locations

Country	Name	City	State
Egypt	Tanta university	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in DAS-28-CRP score	Patients will undergo clinical assessment according to DAS-28-CRP score	3 months
Primary	The change in Multidimensional Health Assessment Questionnaire (MDHAQ) score		3 months
Secondary	The change in serum level of C-reactive protein (CRP)	Blood samples will be collected at base line and after 3 months	3 months
Secondary	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
Secondary	The change in serum level of Transforming growth factor ß1(TGF-ß1).	Blood samples will be collected at base line and after 3 months	3 months