Clinical Study Evaluating the Effect of Diosmin and Hesperidin in Treatment of Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Anti inflammatory Effect
研究概览
简要总结
Evaluating the effect of the flavonoids combination (diosmin and hesperidin) as adjuvant therapy on patients with rheumatoid arthritis
详细描述
Evaluation of the anti inflammatory and antioxidant effects of the flavonoids combination (diosmin and hesperidin) as adjuvant therapy on patients with rheumatoid arthritis.
Clinical and functional assessment of disease activity.
Evaluation of hepatoprotective effect against methotrexate induced liver adverse events.
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild to moderate disease activity.
- •Patient age must be more than 18 years.
排除标准
- •Pregnant and lactating females.
- •Patients with liver, renal impairment or any other inflammatory diseases.
- •Patients on TNF-α or IL-1β antagonists.
研究组 & 干预措施
Intervention group
Diosmin 450 mg and Hesperidin 50 mg Combination /tablet/ twice daily for 3 months + Conventional Therapy (Methotrexate)
干预措施: Diosmin and Hesperidin Combination (Drug)
结局指标
主要结局
Anti inflammatory Effect
时间窗: 3 months
Measure the change in serum level of IL-1β (interleukin 1β) at baseline and after treatment in both groups
Effect on disease activity
时间窗: 3 months
Measure the change in the disease activity at baseline and after 3 months of therapy for each patient in both groups using Disease Activity Score-CRP (DAS28-CRP) which is calculated by a computer based formula consists of several variables: number of swollen joints (0-28), number of tender joints (0-28) and C reactive protein (CRP) (mg/l). A DAS28 value of \>5.1 indicates high disease activity, DAS28 ranged from 3.3 to 5.1 indicates moderate disease activity and DAS28 ≤3.2 indicates low disease activity.
次要结局
- Hepatoprotective Effect(3 months)