The effects of melatonin on oxidative pathways in patients with acute ischemic stroke
Design
Based on the randomization table (permuted block method in blocks of 4), patients are candidates to receive melatonin or placebo for 5 days. All patients included in the study, who are 60 and placed in parallel groups, will receive a standard treatment regimen.
Settings and conduct
Patients with MS referred to Bo Ali Sina Educational Center who meet the inclusion criteria and do not have the exclusion criteria are included in the study and are divided into two groups according to the randomization table and are evaluated for 12 weeks. The treating doctor, the patient and the evaluator are unaware of the type of therapeutic intervention.
Participants/Inclusion and exclusion criteria
Adults over 18 years of age with diagnosis of acute ischemic stroke according to brain CT scan findings will be included. Pregnant and lactating women, people with severe psychiatric disorders, severe hepatic insufficiency, NIHSS more than 25, and lacunar infarct will be excluded from the study.
Intervention groups
Intervention: Melatonin 30 mg daily for 5 days
Control: Placebo (same shape and color) daily for 5 days
Main outcome variables
The effectiveness of melatonin on inflammatory biomarkers serum levels reduction, Oxidative stress biomarker serum levels reduction, stroke induced disability improvement according to mRS, Melatonin tolerability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190804044429N10
Registration date:2023-01-22, 1401/11/02
Registration timing:registered_while_recruiting
Last update:2023-01-22, 1401/11/02
Update count:0
Registration date
2023-01-22, 1401/11/02
Registrant information
Name
Monireh Ghazaeian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 6864
Email address
ghazaeianm@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of melatonin on oxidative pathways in patients with acute ischemic stroke: A randomized double-blind clinical trial
Public title
Melatonin ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults over the age of 18 and diagnose with acute ischemic stroke according to brain CT scan findings
NIHSS more than 4
Exclusion criteria:
Hemorrhagic stroke
Lacunar infarct
TIA
NIHSS more than 25
Pregnancy
Lactation
Severe hepatic insufficiency
History of apnea
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization using the block method by a person who is not related to the study. Packages containing the drug and placebo are completely similar in shape and color. Randomization of serial numbers of drug packages and placebo by a person who is not involved in the project according to randomized table. The number of the bottle corresponded with the number of the patient. Random block method will be used to allocate the samples to two groups. Blocks will be considered as 4 blocks and in each block of 4 people, two people in the intervention group and two people in the control group will be selected. The selection of the order type in each group for each person will be done through second version of random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double_ blind. Outcome elevator and participant are blinded (double blind) and aware from grouping (intervention or placebo)
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran university of medical Sciences
Street address
Ibn Sina hospital, Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
4816864193
Approval date
2022-08-10, 1401/05/19
Ethics committee reference number
IR.MAZUMS.REC.1401.258
Health conditions studied
1
Description of health condition studied
Cerebellar stroke syndrome
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
Glutathione serum level
Timepoint
days 0 and 5th of the study
Method of measurement
Spectroscopy
2
Description
Antioxidant serum levels
Timepoint
at days 0 and 5th of the study
Method of measurement
Spectroscopy
Secondary outcomes
1
Description
Disability following stroke
Timepoint
At days 0, discharge and month three of the study
Method of measurement
According to mRS
2
Description
Tolerability of melatonin
Timepoint
During the study period
Method of measurement
History taking
Intervention groups
1
Description
Intervention group: patients in the intervention group will receive 30 mg melatonin following acute ischemic stroke for 5 days
Category
Treatment - Drugs
2
Description
Control group: patients in the control group will receive a placebo in the form of tablets with the same color, size and packaging as the intervention group and without the active pharmaceutical ingredient for five days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina hospital
Full name of responsible person
Monireh Ghazaeian
Street address
Pasdaran Blvd.
City
Sari
Province
Mazandaran
Postal code
4816864193
Phone
+98 11 3448 4800
Fax
+98 11 3334 3989
Email
ghazaeianm@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahimnejad
Street address
Vice chancellor for Research, Mazandaran University of medical Sciences, Joybar 3way, Sari,Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3448 4800
Email
pebrahimnejad@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Mazandaran University of Medical Sciences
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Clinical pharmacy
Street address
Ibn Sina hospital, Pasdaran Blvd, Sari, Mazandaran province, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 33343011
Email
Ghazaeianm@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Monireh Ghazaeian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Clinical pharmacy
Street address
Ibn Sina hospital, Pasdaran Blvd, Sari, Mazandaran province, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3334 3011
Email
Ghazaeianm@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Monireh Ghazaeian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Ibn Sina hospital, Pasdaran Blvd, Sari, Mazandaran province, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3334 3011
Email
Ghazaeianm@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data related to the initial outcoms of the study will be shared
When the data will become available and for how long
The data will be available one year after publication
To whom data/document is available
Academic reseachers, medical team and scientific institutes
Under which criteria data/document could be used
Requests for sharing data should be sent to the person responsible for general inquiries
From where data/document is obtainable
Requests for sharing data should be sent to the person responsible for general inquiries. Ghazaeianm@gmail.com
What processes are involved for a request to access data/document
Person in charge of scientific study will reply to the request within 10 days