L-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis

Phase 3RecruitingNCT05792527

Tanta University46 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

L-carnitineDRUG

One 500 mg tablet twice daily after meals

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tanta university

Tanta, Gharbia Governorate, Egypt

RECRUITING

Outcomes

Primary Outcomes

The change in DAS-28-CRP score

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

Time frame: 3 months

The change in Multidimensional Health Assessment Questionnaire (MDHAQ) score

Time frame: 3 months

Secondary Outcomes

The change in serum level of C-reactive protein (CRP)

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

Time frame: 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

Time frame: 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

Time frame: 3 months

Central Contacts

Abdallah A Eldisouky

CONTACT

201279142631 PG_165476@pharm.tanta.edu.eg

Data from ClinicalTrials.gov

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