Back to resultsL-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
L-carnitine
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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.
Sites / Locations
- Tanta universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
control group
L-carnitine group
Arm Description
this group will include 23 patients which will receive the traditional therapy of RA for 3 months.
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.
Outcomes
Primary Outcome Measures
The change in DAS-28-CRP score
Patients will undergo clinical assessment according to DAS-28-CRP score
The change in Multidimensional Health Assessment Questionnaire (MDHAQ) score
Secondary Outcome Measures
The change in serum level of C-reactive protein (CRP)
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).
Blood samples will be collected at base line and after 3 months
The change in serum level of Transforming growth factor β1(TGF-β1).
Blood samples will be collected at base line and after 3 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05792527
Brief Title
L-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis
Official Title
The Use of L-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2023 (Actual)
Primary Completion Date
March 5, 2025 (Anticipated)
Study Completion Date
March 5, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
this group will include 23 patients which will receive the traditional therapy of RA for 3 months.
Arm Title
L-carnitine group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
L-carnitine
Intervention Description
One 500 mg tablet twice daily after meals
Primary Outcome Measure Information:
Title
The change in DAS-28-CRP score
Description
Patients will undergo clinical assessment according to DAS-28-CRP score
Time Frame
3 months
Title
The change in Multidimensional Health Assessment Questionnaire (MDHAQ) score
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The change in serum level of C-reactive protein (CRP)
Description
Blood samples will be collected at base line and after 3 months
Time Frame
3 months
Title
The change in serum level of Signal transducer and activator of transcription 3(STAT 3).
Description
Blood samples will be collected at base line and after 3 months
Time Frame
3 months
Title
The change in serum level of Transforming growth factor β1(TGF-β1).
Description
Blood samples will be collected at base line and after 3 months
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdallah A Eldisouky
Phone
201279142631
Email
PG_165476@pharm.tanta.edu.eg
Facility Information:
Facility Name
Tanta university
City
Tanta
State/Province
Gharbia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdallah A Eldisouky
Phone
201279142631
Email
PG_165476@pharm.tanta.edu.eg
12. IPD Sharing Statement
Learn more about this trial
L-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis
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