Evaluation of melatonin as a potential drug for the improvement of clinical outcome, reduction of infarct size, sleep parameters and cognitive functions in post-stroke patients: A randomized, double blind, placebo-controlled study
The aim of this study is to evaluate the effects of melatonin on clinical outcome (functional and neuro-cognitive) and sleep parameters in post-stroke patients.
A randomized, double-blind, placebo-controlled study will be conducted including 60 cases of ischemic-stroke. Subjects will be enrolled in the study if they meet the inclusion criteria including: Clinical diagnosis of acute stroke in middle cerebral artery (MCA) territory (left or right MCA), 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 (for either one arm or leg); Signed informed consent and Level of consciousness less than 2 in NIHSS scale. Patients will be excluded from the study if they have: Clinically relevant preexisting neurological deficit or previous CVA; Primary intracerebral hemorrhage; Coma (level of consciousness more than 2 in NIHSS scale); or Negative swallow test. Patients eligible to participate in the study,will randomly be divided into two groups (N=30/group) and will receive either melatonin (6mg/day at bed time) (treatment group) or cellulose (6mg/day at bed time) (placebo group) for 90 days. Before and 90 days after treatment, patients will be assessed for: 1) clinical functional outcome using modified NIHSS and MRS score; 2) infarct size using voxel-based volumetry; 3) sleep parameters subjectively using PSQI and PIRS questionnaires and objectively using full-setup overnight polysomnography (the polysomnography will be applied on patients who have poor sleep according to PSQI and PIRS questionnaires); and 4) cognitive functions using the Addenbrook’s Cognitive Examination.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201609059566N2
Registration date:2016-12-17, 1395/09/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-17, 1395/09/27
Registrant information
Name
Masoumeh Emamghoreishi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 7591
Email address
emamm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Shiraz University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of melatonin as a potential drug for the improvement of clinical outcome, reduction of infarct size, sleep parameters and cognitive functions in post-stroke patients: A randomized, double blind, placebo-controlled study
Public title
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.
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
permuted block randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Science
Street address
Shiraz-Zand street-opposite of Felestin street-
City
Shiraz
Postal code
14336 - 71348
Approval date
2016-08-21, 1395/05/31
Ethics committee reference number
ir.sums.rec.1395.104
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
163
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Clinical outcome
Timepoint
90 days
Method of measurement
NIHSS and MRS questionnairies
2
Description
Cognitive function
Timepoint
90 days
Method of measurement
Addenbrook questionnaire
3
Description
Infarct size
Timepoint
90 days
Method of measurement
Voxel-based volumetry
4
Description
Subjective sleep assessment
Timepoint
90 days
Method of measurement
self-rated 19-item PSQI questionnaire and PIRS questionnaire
5
Description
Objective sleep assessment
Timepoint
90 days
Method of measurement
polysomnography
Secondary outcomes
empty
Intervention groups
1
Description
placebo (microcrystalline cellulose powder [Avicel], 6mg/day at bed time) for 90 days
Category
Placebo
2
Description
melatonin (6 mg/day at bed time) for 90 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital (a tertiary medical center affiliated with Shiraz University of Medical Sciences, Sh
Full name of responsible person
Dr. Afshin Borhan Haghighi
Street address
Namazi Square- Namazi Hospital- Department of Neurology
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr. Postfrosh
Street address
Shiraz-Zand street-opposite of Felestin street-
City
shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr.Masoumeh Emamghoreishi
Position
Full Professor/Ph.D
Other areas of specialty/work
Street address
Zand Street, School of Medicine, Department of Pharmacology
City
shiraz
Postal code
Phone
+98 71 3230 7591
Fax
Email
emamm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Dr.Masoumeh Emamghoreishi
Position
Full Professor/ PhD
Other areas of specialty/work
Street address
Zand Street, School of Medicine, Department of Pharmacology
City
shiraz
Postal code
Phone
+98 71 3230 7591
Fax
Email
emamm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
shiraz university of medical sciences
Full name of responsible person
Dr. Reza Dehghani
Position
DVM/PhD student in Pharmacology
Other areas of specialty/work
Street address
Zand street- School of Medicine- Department of Pharmacology
City
shiraz
Postal code
Phone
+98 71 3230 7591
Fax
Email
emamm@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)