Clinical Study Comparing Diosmin vs Rebamipide as Adjuvant Therapies vs Conventional Therapy in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The change in Disease Activity score-CRP (DAS28-CRP)
研究概览
简要总结
This study will be a randomized controlled parallel study that will be conducted on 66 patients with active rheumatoid arthritis who will be diagnosed with RA according to American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR, 2010). The patients will be recruited from Outpatient Clinic of Rheumatology, Physical Medicine, Rheumatology and Rehabilitation Department, Tanta University Hospital, Tanta, Egypt. The study duration will be 3 months. The patients will be randomized into three groups:
- Group 1 (control group): will include 22 patients who will receive the conventional therapy for RA for 3 months.
- Group 2 (diosmin group): will include 22 patients who will receive the conventional therapy for RA plus 1000 mg diosmin once daily for 3 months.
- Group 3 (rebamipide group): will include 22 patients who will receive the conventional therapy for RA plus 100 mg rebamipide three times daily for 3 months.
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.
- •Both sexes.
- •Age ranges between 18 and 70 years old.
- •Patients receiving conventional DMARDs
排除标准
- •Pregnant and lactating females.
- •Patients receiving biological DMARDs or targeted synthetic DMARDs.
- •Patients with renal and hepatic dysfunction.
- •Patients with other inflammatory/autoimmune diseases, active infection, or malignancies.
- •Patients with bleeding disorders, receiving warfarin or other anticoagulants.
- •Patients receiving antioxidants.
- •Patients with hypersensitivity to study medications.
结局指标
主要结局
The change in Disease Activity score-CRP (DAS28-CRP)
时间窗: At baseline and after three months of the intervention
disease activity will be assessed through: Calculation of 28-joint count Disease Activity Score (DAS28) using C- reactive protein level (CRP) according to the following formula: DAS28-CRP = \[0.56\*√ (tender joint count) + 0.28\*√ (swollen joint count) + 0.36\*ln (CRP+1)\]\*1.10 + 1.15\]
The change in The Health Assessment Questionnaire-Disability Index (HAQ-DI) score
时间窗: At baseline and after three months of the intervention
the functional status of the participants will be assessed through: The Health Assessment Questionnaire-Disability Index (HAQ-DI)
次要结局
- The change in serum level of Matrix metalloproteinase-3 (MMP-3)(three months)
- The change in serum level of C- reactive protein (CRP)(three months)
- The change in serum level of Tumor necrosis factor-alpha (TNF-α)(three months)
研究者
Khlood Mohamed Kettana
clinical pharmacy assistant lecturer
Tanta University