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临床试验/CTRI/2024/06/068413
CTRI/2024/06/068413尚未招募2 期

Efficacy of Waj in post-stroke cognitive impairment: A Randomized Placebo Controlled Trial

National Institute of Unani Medicine1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月10日最近更新:
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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
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Ruksar Ayesha

National institute of unani medicine, Kottigepalya, Magadi main road Bangalore KARNATAKA

研究点 (1)

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