CTRI/2011/07/001922已完成3 期
A prospective, multicentric, double-blind, randomised, phase III clinical study to compare the efficacy and safety of intravenous Kallikrein versus placebo alongwith standard supportive care in subjects of mild to moderate ischecmic stroke.
Bharat Serums and Vaccines Ltd0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Mild to moderate cerebral ischemic strokes presenting within
- •48 hours after onset of symptoms. (NIHSS score: 4-10, mild;
- •11-20, moderate)
- •2. Male or female, aged 18 to 70 years (both inclusive)
- •3. No hemorrhage as proved by cerebral CT scan
排除标准
- •1. Mean arterial blood pressure > 180/110
- •2. NIHSS score: >21
- •3. Age <18 or >70 years
- •4. History of dementia or neurodegenerative disease
- •5. Severe comorbid condition such as cancer that would limit
- •survival during 3 month follow-up period
- •6. Women of childbearing potential
- •7. Peptic ulcer disease, Active bleeding diathesis, Lower GI bleed
- •8. Hematuria
- •9. Prolonged PT or PTT, Thrombocytopenia or neutropenia
- •10. Elevated LFT / RFT
研究者
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