Studying the effect of melatonin on infarct size in patients with ischemic stroke hospitalized in the neurology department of Imam Khomeini Hospital, Urmia.
Design
A single-blind, parallel-group, controlled clinical trial with 40 patients. Patients will be assigned to the intervention and control groups using random numbers generated in Random allocation software.
Settings and conduct
Patients with acute ischemic stroke admitted to Imam Khomeini Hospital in Urmia are randomly assigned to intervention and control groups. The study is single-blinded, so that the form of the drugs and placebo are completely identical and the patient will not know the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 to 80 years;
Ability and willingness to participate in the study (obtaining informed consent);
Acute stroke that occurred within 7 days prior to admission to the ward;
Diagnosis of acute ischemic stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) at the time of admission. Exclusion criteria:
History of myocardial infarction; prior primary hemorrhagic stroke; significant cognitive impairment or dementia before the stroke; other neurological diseases (e.g., Parkinson’s disease); severe liver disease; severe kidney disease; severe thyroid disease; severe cardiac, respiratory, or organ failure
Intervention groups
Intervention group: Routine treatment including antiplatelet and atorvastatin plus melatonin tablets 20 mg daily for 5 days. Control group: Routine treatment plus placebo tablets containing starch (made by the Faculty of Pharmacy) 20 mg daily for 5 days
Main outcome variables
Size of cerebral infarction (volume of ischemic area)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241229064208N2
Registration date:2025-10-14, 1404/07/22
Registration timing:prospective
Last update:2025-10-14, 1404/07/22
Update count:0
Registration date
2025-10-14, 1404/07/22
Registrant information
Name
Rezvan norouzzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
norouzzade.r@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-22, 1404/10/01
Expected recruitment end date
2026-06-21, 1405/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of melatonin versus placebo on infarct size in patients with ischemic stroke
Public title
Effect of melatonin in patients with ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 80 years
Ability and willingness to participate in the study (obtaining informed consent)
Acute stroke that occurred within 7 days prior to admission to the ward
Diagnosis of acute ischemic stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) at the time of admission
Exclusion criteria:
Patient with a history of heart attack
Primary hemorrhagic stroke
Pre-stroke diagnosis indicating significant decline in mental function or impairment
A valid neurological disease in addition to stroke, such as Parkinson's disease
Severe liver, kidney, or thyroid disease, or heart failure, respiratory failure, or other organ failure
Chronic inflammatory diseases, immune or hematological disorders
History of depression (clinical diagnosis or previous treatment) or other mental disorders
Patients who are not accessible
Age
From 18 years old to 80 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Forty patients will be randomly assigned to two groups: intervention and control. Randomization will be performed using block randomization. First, blocks of size 5 with the sequence (ABABA) will be listed, and each block will be assigned a code. Based on the total sample size of 40, 8 blocks will be selected, and patients will be assigned to the intervention and control groups according to these codes.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be conducted in a single-blinded manner, so that the form of the drugs and placebo will be completely identical and the patient will not know the type of intervention.and control groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Imam Khomeini Educational and Medical Center, Urmia University of Medic
Street address
Imam Khomeini University Hospital, Ershad Ave, Modarres Blvd, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Approval date
2025-07-30, 1404/05/08
Ethics committee reference number
IR.UMSU.HIMAM.REC.1404.039
Health conditions studied
1
Description of health condition studied
Acute Ischemic Stroke
ICD-10 code
I63.9
ICD-10 code description
Cerebral infarction, unspecified
Primary outcomes
1
Description
• Size of cerebral infarction (volume of ischemic area)
Timepoint
1. Baseline (before intervention) – in the first 7 days after stroke and before treatment begins, 2. Follow-up (follow-up) – three months after intervention
Method of measurement
Brain CT scan
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment includes antiplatelet and atorvastatin plus melatonin tablets 20 mg daily for 5 days.
Category
Treatment - Drugs
2
Description
Control group: Routine treatment with placebo tablets containing starch (made by the Faculty of Pharmacy) 20 mg daily for 5 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Imam Khomeini Hospital
Full name of responsible person
Dr. Rizvan Norouzzadeh
Street address
Imam Khomeini University Hospital., Ershad Ave., Modarres Blvd., Urmia.,
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Fax
+98 44 3346 9935
Email
norouzzade.r@umsu.ac.ir
Web page address
http://Imam.umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Saber Gholizadeh
Street address
Urmia University of Medical Sciences, Orjans Alley, Resalat Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5718748983
Phone
+98 44 3237 5907
Email
sabergholizadeh@yahoo.com
Web page address
http://umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Rizvan Norouzzadeh
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Imam Khomeini University Hospital, Ershad Ave, Modarres Blvd, Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Fax
Email
norouzzade.r@umsu.ac.ir
Web page address
http://Imam.umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Rizvan Norouzzadeh
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Imam Khomeini University Hospital, Ershad Ave., Modarres Blvd., Urmia., Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Email
norouzzade.r@umsu.ac.ir
Web page address
http://Imam.umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Rizvan Norouzzadeh
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Imam Khomeini University Hospital, Ershad Ave., Modarres Blvd., Urmia., Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Email
norouzzade.r@umsu.ac.ir
Web page address
http://Imam.umsu.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