CTRI/2024/06/068413尚未招募2 期
Efficacy of Waj in post-stroke cognitive impairment: A Randomized Placebo Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- • Improvement in Montreal Cognitive Assessment (MoCA) to evaluate the general cognitive function
研究概览
简要总结
Purpose: To Evaluate the Efficacy of Waj in Post-stroke Cognitive Impairment
Design: A Double Blind Randomized Placebo Controlled Study
Intervention: Test group will be given research drug (Waj) 3gm in two divided doses daily and control group will be given placebo (wheat flour) same as test group
Main outcome measures:
Primary outcome: Improvement in Montreal Cognitive assessment Score
Secondary outcome: Improvement in Activities of daily living assessed by Barthel Index
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Age ranges from 30 to 75 years (30 and 75 also included), no gender limitation.
- •The presence of cognitive impairments (Montreal Cognitive Assessment, MoCA less than 26).
- •Patients having single ischaemic or haemorrhagic stroke documented by cerebral CT scanning or MRI before enrolment.
- •Patients having history of stroke more than 6 weeks.
- •No severe aphasia and able to accomplish cognitive tests.
- •Stable vitals, no progression of neurological symptoms.
- •Normal cognitive function before stroke.
- •Educational level should be primary school or above, with the capability of finishing cognitive tests.
排除标准
- •Patients with pre stroke cognitive impairment.
- •Any neuropsychiatric comorbidity and affective disorder that could influence the test outcomes.
- •Patients with uncorrectable visual or hearing disturbances severe enough to preclude cognitive tests.
- •Severe Aphasia.
- •Chronic Alcoholism.
- •Uncontrolled hypertension and Diabetes mellitus.
- •A medical condition that, in the investigator opinion, would interfere with treatment, safety, or adherence to the protocol.
结局指标
主要结局
• Improvement in Montreal Cognitive Assessment (MoCA) to evaluate the general cognitive function
时间窗: 0, 14th, 28th, and 42nd day
次要结局
- • Improvement in Activities of Daily Living (ADL) assessed with the Barthel Index (BI)(0,and 42nd day)
研究者
Dr Ruksar Ayesha
National institute of unani medicine, Kottigepalya, Magadi main road Bangalore KARNATAKA
研究点 (1)
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