Rheumatoid ArthritisPhase 3NCT05792527
L-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis
A Phase 3 study testing L-carnitine in people with Rheumatoid Arthritis, run by Tanta University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- L-carnitine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Mar 2023to 5 Mar 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta university
Tanta, Gharbia Governorate
Abdallah A Eldisouky, 201279142631, PG_165476@pharm.tanta.edu.eg
About this study
Official title: 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
- Conditions
- Rheumatoid Arthritis
- Being tested
- L-carnitine
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-carnitineDrug
One 500 mg tablet twice daily after meals
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | this group will include 23 patients which will receive the traditional therapy of RA for 3 months. |
| L-carnitine group | Active comparator | 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. Receives: Drug: L-carnitine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in DAS-28-CRP score
Patients will undergo clinical assessment according to DAS-28-CRP score
Measured: 3 months
The change in Multidimensional Health Assessment Questionnaire (MDHAQ) score
Measured: 3 months
Secondary outcomes (3)
The change in serum level of C-reactive protein (CRP)
Blood samples will be collected at base line and after 3 months
Measured: 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
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start5 Mar 2023
- Primary completion5 Mar 2025 (estimated)
- Study completion5 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Abo-Elazm Shebl Eldisouky, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792527
- Sponsor's protocol ID
- L-carnitine in RA
- Status last verified
- Mar 2023
- First submitted
- 19 Mar 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of L-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT05792527
- Acronym / sponsor ID
- L-carnitine in RA
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 5 Mar 2023 (actual)
- Primary completion
- 5 Mar 2025 (estimated)
- Study completion
- 5 Mar 2026 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –this group will include 23 patients which will receive the traditional therapy of RA for 3 months. |
| L-carnitine group | Active comparator | Drug: L-carnitinethis 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-carnitineOne 500 mg tablet twice daily after meals | Drug | L-carnitine group |
Primary outcome
The change in DAS-28-CRP score
Time frame: 3 months
Patients will undergo clinical assessment according to DAS-28-CRP score
The change in Multidimensional Health Assessment Questionnaire (MDHAQ) score
Time frame: 3 months
3 secondary outcomes
The change in serum level of C-reactive protein (CRP)
Time frame: 3 months
The change in serum level of Signal transducer and activator of transcription 3(STAT 3).
Time frame: 3 months
The change in serum level of Transforming growth factor β1(TGF-β1).
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing L-carnitine in people with Rheumatoid Arthritis, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdallah A Eldisouky (201279142631, PG_165476@pharm.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in DAS-28-CRP score (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.