Clinical Study Evaluating the Effect of Nicorandil as Anti-inflammatory and Immune Modulatory in Patients With Rheumatoid Arthritis
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
- change in DAS-28-CRP score
研究概览
简要总结
This study aims to evaluate the possible efficacy and safety of nicorandil as anti-inflammatory in managing patients with active rheumatoid arthritis.
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) i.e., 28 joints disease activity score (DAS-28) >2.
- •Patients receiving the conventional DMARDs
排除标准
- •Patients with heart disease (congestive heart failure, arrhythmia and ischemic heart disease), diabetes, active infection, and other illness except rheumatoid arthritis.
- •Patients with severe renal and hepatic dysfunction. - Patients receiving biological DMARDs.
- •Patients receiving oral prednisolone greater than 15mg/day.
- •Patients with hypersensitivity to study medications.
- •Patients using antioxidants.
- •Pregnant and lactating females.
研究组 & 干预措施
control group
this group will include 23 patients who will receive their traditional therapy of RA for 3 months.
结局指标
主要结局
change in DAS-28-CRP score
时间窗: 3 months
Calculation of 28-joint count Disease Activity Score (DAS28) using C- reactive protein level (CRP)
change in Multidimensional Health Assessment Questionnaire (MDHAQ) scores.
时间窗: 3 months
Before and 3 months after the intervention, the validated Arabic Multidimensional Health Assessment Questionnaire (MDHAQ) Physical Function: Assessed through 10 activities, scored 0-3 (without difficulty=0, some=1, much=2, unable=3), with higher scores indicating worse function
change in 28-joint count Disease Activity Score (DAS28) using C- reactive protein level (CRP)
时间窗: 3 months
Calculation of 28-joint count Disease Activity Score (DAS28) using C- reactive protein level (CRP) where: Remission: \< 2.6. Low Disease Activity (LDA): ≤ 3.2. Moderate Disease Activity (MDA): 3.2 - 5.1. High Disease Activity (HDA): \> 5.1
次要结局
- The change in the serum level of 8-hydroxydeoxyguanosine (8-OHdG).(3 months)
- The change in the serum level of Interleukin 6 (IL-6).(3 months)
- The change in the serum level of C- reactive protein (CRP).(3 months)
- The change in the serum level of 8-hydroxydeoxyguanosine (8-OHdG) at baseline and after 3 months.(3 months)
- The change in the serum level of Interleukin 6 (IL-6) at baseline and after 3 months .(3 months)
- The change in the serum level of C- reactive protein (CRP) at baseline and after 3 months.(3 months)
研究者
Karim Abu El Fath Hussein Abd El Hakim
demonstrator at clinical pharmacy department, faculty of pharmacy, Tanta University
Tanta University