Neuroprotective Efficay of Nebivolol Vs Amlodipine in patients with ischemic stroke-A pilot randomized controlled clinical trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The primary outcome is to compare National Institute of Health Stroke Scale (NIHSS) score modified Barthel Index (mBI) and modified Rankin Scale (mRS) score at admission and on days 30 and 90
研究概览
简要总结
Stroke is one of the leading causes of disability worldwide. Currently the only drug available for the treatment of stroke is alteplase. However the disadvantage of the drug is that patients are eligible to be given this drug only if they present to the hospital within 4.5 hrs of onset of stroke symptoms. Physiotherapy remains the only option left to improve disability in these patients. So there is a definite need to identify novel drugs for preventing disability due to stroke. Nebivolol is a third-generation beta blocker, that has been used in the treatment of hypertension for the past 15 years. Besides reducing the blood pressure, Nebivolol also has the property of reducing oxidative stress and improving endothelial dysfunction. So the study is being done to see if nebivolol when given for a period of 7-10 days in acute ischemic stroke could improve the disability related to stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Onset of stroke symptoms ischemic within 6 to 36 hours prior to beginning of treatment.
- •NIHSS score greater or equal to
- •Known case of hypertension or SBP more than 140 mmHg or DBP more than 90 mmHg.
排除标准
- •Haemorrhagic Stroke, other Central Nervous System (CNS) diseases, including brain tumor, demyelinating diseases, inflammatory diseases, a history of craniotomy or severe brain injuries and idiopathic intracranial hypertension.
- •Any known contra-indication to Nebivolol such as severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome, (unless a permanent pacemaker is in place), severe hepatic impairment (Child-Pugh >B).
- •Acute or chronic renal failure.
- •Pre-existing infectious disease requiring other antibiotic therapy.
- •Pregnant Women.
结局指标
主要结局
The primary outcome is to compare National Institute of Health Stroke Scale (NIHSS) score modified Barthel Index (mBI) and modified Rankin Scale (mRS) score at admission and on days 30 and 90
时间窗: baseline 10 days 30 days and 90 days
次要结局
- Adverse Events Monitoring(baseline 10 days 30 days and 90 days)