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Study the effect of Melatonin on physical recovery and sleep quality in elderly with ischemic stroke.

STUDY THE EFFECT OF MELATONIN ON PSYCHOLOGICAL AND PHYSICAL OUTCOME IN OLDER ADULTS WITH ACUTE ISCHEMIC STROKE

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039619
Enrollment
114
Registered
2022-01-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G460- Middle cerebral artery syndrome

Interventions

Intervention1: Melatonin: Dose 20mg, Frequency HS once in night, route oral administration and duration 6 weeks. Control Intervention1: Nil: Nil

Sponsors

Prerak Kumar
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Not give consent Age below 55 years Comorbid medical illness Hemorrhagic stroke Use of steroids, psychotropics Delirium or Dementia.

Design outcomes

Primary

MeasureTime frame
Effect of melatonin on depressive symptoms and on subjective parameters sleep. 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

MeasureTime frame
To assess the effect of melatonin on physical recovery in older adults with acute ischemic stroke To assess the neurogenesis and anti-inflammatory effect of melatonin in older adults with acute ischemic stroke Timepoint: Day 7, Day 21 and Day 42.

Countries

India

Contacts

Public ContactPrerak Kumar

King George’s Medical University

Shrikantsrivastava@kgmcindia.edu9621373167

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026