Clinical Study to Evaluate Safety and Efficacy of Etoricoxib in Patients With Parkinson's Disease Treated With Conventional Treatment
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- - Change in The Unified Parkinson's Disease Rating Scale
研究概览
简要总结
Neuroinflammation is considered one of the most important factors contributing critically to pathophysiology of PD . Recently, high mobility group box-1 (HMGB1) protein has been encoded as a potential inflammatory biomarker in PD. HMGB1 mediates immune response mostly through endothelial cells and macrophage activation via targeting two vital cell receptors; Toll-like receptor 4 (TLR4) and advanced glycation end products (RAGE).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Both male and female will be included.
- •Patients diagnosed with PD according to Unified Parkinson's Disease Rating Scale.
排除标准
- •Breast feeding
- •Patients with significant liver and kidney function abnormalities.
- •Alcohol and / or drug abusers.
- •Patients with known allergy to the study medications
- •Pregnant women and women with planned pregnancy.
- •Patients who are currently using other anti-inflammatory drugs.
研究组 & 干预措施
Control group
(levo-dopa group, n =30) who will receive levo-dopa/carbidopa (125/12.5) mg three times daily for 6 months.
干预措施: L-dopa (Drug)
Etoricoxib group
will receive levo-dopa/carbidopa (125/12.5) mg three times daily plus Etoricoxib 90 mg once daily
干预措施: L-dopa (Drug)
Etoricoxib group
will receive levo-dopa/carbidopa (125/12.5) mg three times daily plus Etoricoxib 90 mg once daily
干预措施: Etoricoxib (Drug)
结局指标
主要结局
- Change in The Unified Parkinson's Disease Rating Scale
时间窗: 6 months
\- Change in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
次要结局
未报告次要终点
研究者
Ihab Elsayed Hassan
Lecturer
Tanta University