L-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis

March 30, 2023 updated by: Abdallah Abo-Elazm Shebl Eldisouky, Tanta University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in DAS-28-CRP score
Time Frame: 3 months
Patients will undergo clinical assessment according to DAS-28-CRP score
3 months
The change in Multidimensional Health Assessment Questionnaire (MDHAQ) score
Time Frame: 3 months
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2023

Primary Completion (Anticipated)

March 5, 2025

Study Completion (Anticipated)

March 5, 2026

Study Registration Dates

First Submitted

March 19, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

March 31, 2023

Study Record Updates

Last Update Posted (Actual)

March 31, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L-carnitine in RA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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