Evaluation of the Effect of Melatonin on Clinical Outcomes in Patients with Acute Ischemic Stroke: a Randomized Double-Blind Placebo-Controlled Clinical Trial
To assess the effect of Melatonin on clinical outcomes in patients with acute ischemic stroke
Design
This is a double-blind randomized clinical trial, phase III, in which 70 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with acute ischemic stroke referring to the Booali hospital in Tehran city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the Random allocation software. 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:18 to 85 years old, occurrence of stroke within the past 24 hours, NIHSS score of at least 4 and at most 27, not eligible for thrombolytic therapy and thrombectomy.
Exclusion criteria: pregnancy or breastfeeding, acute or chronic intracranial hemorrhage or aneurism, any type of cognitive or behavioral disorder, concurrent inflammatory disease and/or malignancy, patients with transient ischemic attacks, sensitivity to Melatonin.
Intervention groups
Intervention group: routine treatment plus Melatonin tablets (made by Jalinus Pharmaceutical Co.) 10 mg daily for 5 days.
Control group: routine treatment plus placebo tablets (made by Jalinus Pharmaceutical Co. ) 10 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:IRCT20231220060484N1
Registration date:2023-12-27, 1402/10/06
Registration timing:registered_while_recruiting
Last update:2023-12-27, 1402/10/06
Update count:0
Registration date
2023-12-27, 1402/10/06
Registrant information
Name
Amirhossein Ghanbarzamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4406 9924
Email address
amirh.ghzamani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-19, 1402/09/28
Expected recruitment end date
2024-09-09, 1403/06/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Melatonin on Clinical Outcomes in Patients with Acute Ischemic Stroke: a Randomized Double-Blind Placebo-Controlled Clinical Trial
Public title
Protective effect of Melatonin on clinical outcomes in patients with acute ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age:18 to 85 years old
Occurrence of stroke within the past 24 hours
NIHSS score of at least 4 and at most 27
Not eligible for thrombolytic therapy and thrombectomy
Exclusion criteria:
Pregnancy or breastfeeding
Acute or chronic intracranial hemorrhage or aneurism
Any type of cognitive or behavioral disorder
Concurrent inflammatory disease and/or malignancy
Patients with transient ischemic attacks
Sensitivity to Melatonin
Age
From 18 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The blocking process has two stages. In the first stage, the samples with entry criteria are selected by census and in the second stage, the block method will be used for randomization.
Blocking process will be done with a random allocation software and the size of the blocks are predicted to be in four. As a result, the number of blocks will be equal to 18.
After obtaining informed consent, as predicted by the software the samples are entered in one of A or B groups. Also in order to avoid from identification of A and B groups, instead of A or B labels each participant will be assigned by a random 4-digit code obtained from the computer.
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 Department of Pharmaceutical Sciences,Tehran Islamic Azad University of Medical
Street address
Islamic Azad University of Pharmaceutical Sciences Branch, Yakhchal Ave., Gholhak, Dr Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2023-12-12, 1402/09/21
Ethics committee reference number
IR.IAU.PS.REC.1402.522
Health conditions studied
1
Description of health condition studied
Acute ischemia stroke
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 Jalinus Pharmaceutical Co.) 10 mg daily for 5 days
Category
Treatment - Drugs
2
Description
Control group: routine treatment plus placebo tablets including starch (made by Jalinus Pharmaceutical Co. ) 10 mg daily for 5 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Booali hospital
Full name of responsible person
Mahsa rabiee
Street address
Booali Hospital, not reaching Imam Hossein Square, Damavand Street
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Email
booali.hospital96@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Amirhossein Ghanbarzamani
Street address
No 99, Yakhchal street, Gholhak, Dr Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0599
Email
amirh.ghzamani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
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
Islamic Azad University
Full name of responsible person
Amirhossein Ghanbarzamani
Position
Clinical pharmacologist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 99, Yakhchal street, Dr Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0056
Email
amirh.ghzamani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amirhossein Ghanbarzamani
Position
Clinical Pharmacologist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 99, Yakhchal street, Dr Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0056
Email
amirh.ghzamani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahsa Rabiee
Position
Pharmacy Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No. 99, Yakhchal street, Dr Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0056
Email
mahsa.rb1998@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no plan for publishing the protocol of study because it is accessible in IRCT
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
All data are shareable after publishing
When the data will become available and for how long
Start the access period 6 months after publishing the result
To whom data/document is available
All researchers
Under which criteria data/document could be used
For used in clinical practice and also future meta-analysis
From where data/document is obtainable
amirh.ghzamani@gmail.com
What processes are involved for a request to access data/document