NCT05792527招募中3 期
The Use of L-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The change in DAS-28-CRP score
研究概览
简要总结
This study aims at evaluating the possible efficacy and safety of L-carnitine in rheumatoid arthritis via targeting Jak/STAT pathway and TGF-β1
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Patients receive the conventional DMARDs
- •Both sexes.
- •Age range between 18 and 70 years old.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: L-carnitine (Drug)
结局指标
主要结局
The change in DAS-28-CRP score
时间窗: 3 months
Patients will undergo clinical assessment according to DAS-28-CRP score
The change in Multidimensional Health Assessment Questionnaire (MDHAQ) score
时间窗: 3 months
次要结局
- The change in serum level of C-reactive protein (CRP)(3 months)
- The change in serum level of Signal transducer and activator of transcription 3(STAT 3).(3 months)
- The change in serum level of Transforming growth factor β1(TGF-β1).(3 months)
研究者
Abdallah Abo-Elazm Shebl Eldisouky
principal investigator
Tanta University
研究点 (1)
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