Study the effect of Melatonin on physical recovery and sleep quality in elderly with ischemic stroke.
Phase 3
Completed
- Conditions
- Health Condition 1: G460- Middle cerebral artery syndrome
- Registration Number
- CTRI/2022/01/039619
- Lead Sponsor
- Prerak Kumar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 84
Inclusion Criteria
Above 55 years of age.
Patient who will give consent, evidenced by signature on informed consent form, in case of illiterate subjects by thumb impression.
Diagnosed case of acute ischemic stroke
involving middle cerebral artery territory diagnosed by neuroimaging scan (CT Scan head :assessed by ASPECTS score).
mild( 0-4)and moderate (5-14) severity as per National Institute Health Stroke Scale
Exclusion Criteria
Not give consent
Age below 55 years
Comorbid medical illness
Hemorrhagic stroke
Use of steroids, psychotropics
Delirium or Dementia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect of melatonin on depressive symptoms and on subjective parameters sleep. <br/ ><br>Tools: Hamilton Depression Rating scale ( depression) Pittsburgh Sleep Quality Index ( sleep quality), Hindi Mental status exam( Cognition) Modified Rankin scale ( Stroke physical recovery) National Institutes of Health Stroke Scale ( severity of stroke).Timepoint: Week 3rd and week 6th after baseline assessment.
- Secondary Outcome Measures
Name Time Method To assess the effect of melatonin on physical recovery in older adults with acute ischemic stroke <br/ ><br>To assess the neurogenesis and anti-inflammatory effect of melatonin in older adults with acute ischemic stroke <br/ ><br>Timepoint: Day 7, Day 21 and Day 42.