L-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis

• Sponsor: Tanta University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05792527
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: L-carnitine	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Use of L-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis Patients
• Actual Study Start Date: Mar 5, 2023
• Anticipated Primary Completion Date: Mar 5, 2025
• Anticipated Study Completion Date: Mar 5, 2026

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: control group this group will include 23 patients which will receive the traditional therapy of RA for 3 months.
Active Comparator: L-carnitine group 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.	Drug: L-carnitine; One 500 mg tablet twice daily after meals

Outcome Measures

Primary Outcome Measures

1. The change in DAS-28-CRP score [3 months]

   Patients will undergo clinical assessment according to DAS-28-CRP score

2. The change in Multidimensional Health Assessment Questionnaire (MDHAQ) score [3 months]

Secondary Outcome Measures

1. The change in serum level of C-reactive protein (CRP) [3 months]

   Blood samples will be collected at base line and after 3 months

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta university	Tanta	Gharbia	Egypt

Sponsors and Collaborators

• Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abdallah Abo-Elazm Shebl Eldisouky, principal investigator, Tanta University
• ClinicalTrials.gov Identifier: NCT05792527
• Other Study ID Numbers: L-carnitine in RA
• First Posted: Mar 31, 2023
• Last Update Posted: Mar 31, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Inflammation

Study Results

No Results Posted as of Mar 31, 2023