CTRI/2020/11/029182已完成3 期
Study the clinical, biochemical, genetic and radiological profile of cerebral small vessel disease and to investigate the clinical improvement in ischemic stroke patients by Tinospora cordifolia through blinded randomized control trial
Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年11月21日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Functional Outcome (mRS)
研究概览
简要总结
All consecutive acute ischemic stroke, will be recruited for the study. The patient would be randomized in two groups. Both the groups would be receiving standard treatment as per national and international guidelines and one group would receive capsules of Tinospora cordifolia and the other group would receive identical looking capsule and patient would be assessed for functional outcome at 3 months. At each level necessary blinding would be done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Age ≥ 18 years 2.Cases of Ischemic stroke with and without periventricular white matter changes.
排除标准
- •1.Patients denying the consent to participate.
- •2.Traumatic brain injury, vascular aneurysm, arterial malformation, etc.
- •3.History of Central Nervous System (CNS) infections.
- •4.Recurrent ischemic stroke.
结局指标
主要结局
Functional Outcome (mRS)
时间窗: 0 days and at 90 days
次要结局
- NIHSS, MoCA, Clinical Dementia Rating (CDR)(0 days and 90 days)
研究者
研究点 (1)
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