A clinical trial of comparing the effect of melatonin and placebo on improving the neurological complications, infarct size and sleep and cognitive impairments in patients with ischemic stroke.

Phase 3

Recruiting

• Conditions: stroke.; Cerebral infarction

• Registration Number: IRCT201609059566N2
• Lead Sponsor: Shiraz University of Medical Science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Inclusion criteria :
Clinical diagnosis of acute stroke in middle cerebral artery (MCA) territory established by MRI imaging; Males and females between18 to 70 years old; NIHSS score of 5-20 with a motor deficit of 2 or more; Level of consciousness less than 2 in NIHSS scale; Signed informed consent; More than 12 years education
Exclusion criteria :
Clinically relevant preexisting neurological deficit or previous CVA; Primary intracerebral hemorrhage; Coma; Negative swallow test; History of epilepsy or seizure at onset of stroke; Systolic BP is >220 mmHg, diastolic BP>120 ; Atrial fibrillation or other arrhythmias ; Ejection Fraction less than 30%; Aphasia; Malignancy or premalignant state within 5 years; Significant liver disease (Bilirubin > 20 mmoll/L); Respiratory failure (FEV1 < 1.5 L, pO2 < 70 in room air, pCO2 > 45); Psychiatric illness requiring hospital admission; Chronic kidney disease ; NIHSS> 20 ; Pregnancy or breast feeding; Inability to follow up the instructions of the study; Autoimmune disease; Steroid consumption

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical outcome. Timepoint: 90 days. Method of measurement: NIHSS and MRS questionnairies.;Cognitive function. Timepoint: 90 days. Method of measurement: Addenbrook questionnaire.;Infarct size. Timepoint: 90 days. Method of measurement: Voxel-based volumetry.;Subjective sleep assessment. Timepoint: 90 days. Method of measurement: self-rated 19-item PSQI questionnaire and PIRS questionnaire.;Objective sleep assessment. Timepoint: 90 days. Method of measurement: polysomnography.