To assess the effect of melatonin versus placebo on clinical outcomes in patients with ischemic stroke
Design
This is a double-blind randomized clinical trial, phase III, in which 66 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with ischemic stroke referring to the Sina Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be double-blinded so that neither patients nor the physician examining the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18 to 85 years old; acute ischemic stroke for the first time; occurrence of stroke within the past 24 hours; focal neurological disorder; NIHSS score of at least 4 and at most 27.
Exclusion criteria: pregnancy or breastfeeding; acute or chronic intracranial hemorrhage or aneurism; any type of cognitive or behavioral disorder; concurrent inflammatory disease; taking any antioxidant combination in the last month; sensitivity to melatonin.
Intervention groups
Intervention group: routine treatment plus melatonin tablets (made by Razak Pharmaceutical Co.) 20 mg daily for 5 days.
Control group: routine treatment plus placebo tablets (made by School of Pharmacy, Shahid Beheshti University) 20 mg daily for 5 days.
Main outcome variables
The severity of neurological function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N378
Registration date:2021-01-28, 1399/11/09
Registration timing:prospective
Last update:2021-01-28, 1399/11/09
Update count:0
Registration date
2021-01-28, 1399/11/09
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2022-02-04, 1400/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of melatonin versus placebo on clinical outcomes in patients with ischemic stroke: a double-blind randomized clinical trial
Public title
Effect of melatonin versus placebo on clinical outcomes in patients with ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age:18 to 85 years old
Acute ischemic stroke for the first time
Occurrence of stroke within the past 24 hours
Focal neurological disorder
NIHSS score of at least 4 and at most 27
Exclusion criteria:
Pregnancy or breastfeeding
Acute or chronic intracranial hemorrhage or aneurism
Any type of cognitive or behavioral disorder
Concurrent inflammatory disease
Taking any antioxidant combination in the last month
Sensitivity to melatonin
Age
From 18 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-11-08, 1399/08/18
Ethics committee reference number
IR.UMSHA.REC.1399. 679
Health conditions studied
1
Description of health condition studied
Acute ischemia stoke
ICD-10 code
I67.82
ICD-10 code description
Cerebral ischemia
Primary outcomes
1
Description
The severity of neurological function
Timepoint
Before the intervention and on the fifth day and one and three months after the intervention
Method of measurement
Using the National Institutes of Health Stroke (NIHSS) questionnaire and the modified Rankin Scale (mRS) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: routine treatment plus melatonin tablets (made by Razak Pharmaceutical Co.) 20 mg daily for 5 days
Category
Treatment - Drugs
2
Description
Control group: routine treatment plus placebo tablets including starch (made by School of Pharmacy, Shahid Beheshti University) 20 mg daily for 5 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital in Hamadan city
Full name of responsible person
Ensieh Rahmani Yeganeh
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
ncrahmani1995@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ensieh Rahmani Yeganeh
Position
Student of Pharmacy
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
ncrahmani1995@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Davood Ahmadi Moghadam
Position
Pharmacologist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
d.ahmadimoghadam@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available