The aim of the present study is to determine the effect of Melatonin on stroke severity as it is one of the most important determinants of prognosis of the outcome.
In a triple-blind, placebo-controlled clinical trials, 58 patients with ischemic stroke will be randomized to oral Melatonin 3 mg or placebo daily for 2 months. Severity of stroke will be studied by assessing CNSS (Canadian Neurological Scale of Stroke) on baseline and after 2 months of study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015012917811N6
Registration date:2015-02-11, 1393/11/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-11, 1393/11/22
Registrant information
Name
Shayan Amjadi
Name of organization / entity
Students Research Committee,Arak Universiry of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
sh.amjadi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
grant from Office of Vice Chancellor for Research of Arak university of Medical Sciences (GRANT #397)
Expected recruitment start date
2013-06-01, 1392/03/11
Expected recruitment end date
2014-03-31, 1393/01/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of melatonin in clinical improvement of patients with ischemic stroke
Public title
Melatonin and Stroke
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria : Patients admitted in Valiasr Hospital of Arak city with acute ischemic stroke approved by a neurologist and imaging that caused hemiparesis or hemiplegia ; Those who aged between 18 years and 85 years
exclusion criteria : severe post-stroke disability (National Institutes of Health stroke scale [NIHSS] score >20) ; substantial pre-morbid disability ; or a pre-existing deficit that could interfere with assessments— ie residual motor deficit from a previous stroke ; pregnancy and other major diseases that would prevent follow-up
Age
From 18 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences , Sardasht , Arak , Iran
City
Arak
Postal code
Approval date
2013-03-14, 1391/12/24
Ethics committee reference number
92-156-3
Health conditions studied
1
Description of health condition studied
ischemic brain stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Severity of stroke
Timepoint
baseline and after 2 months
Method of measurement
Canadian Neurological Scale of Stroke (CNSS)
Secondary outcomes
empty
Intervention groups
1
Description
intervention group : 1 melatonin tablet (3mg) every night for 2 months.
all patients will receive standard treatment of stroke(Plavix tablet 75mg /daily)
Category
Treatment - Drugs
2
Description
patients whom randomized to placebo group will received placebo tablets during 8 weeks of clinical trial course
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
valiasr hospital
Full name of responsible person
dr. fardin Faraji
Street address
Valiasr hospital, Valiasr sq. , Arak , Iran
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences , Office of Vice Chancellor for Research
Full name of responsible person
Dr.Mohammad Rafii
Street address
Arak University of Medical Sciences , Sardasht , Arak , Iran
City
Arak
Grant name
Grant code / Reference number
397
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences , Office of Vice Chancellor for Research
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
Students Research Committe , Medicine faculty , Arak University of Medical Sciences
Full name of responsible person
Shayan Amjadi
Position
M.D
Other areas of specialty/work
Street address
Arak University of Medical Sciences , Sardasht , Arak , Iran
City
Arak
Postal code
Phone
+98 86 3417 3502
Fax
Email
sh.amjadi@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neurology Department , Medicine faculty, Arak University of Medical Sciences
Full name of responsible person
Fardin Faraji
Position
Neurology specialist,Associate Professor
Other areas of specialty/work
Street address
Arak University Of Medical Sciences , Arak , Iran
City
Arak
Postal code
Phone
+98 86 3417 3502
Fax
Email
dr.faraji@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Students Research Committee , Arak University of Medical Sciences
Full name of responsible person
Shayan Amjadi
Position
M.D
Other areas of specialty/work
Street address
Aak University of Medical Sciences , Arak , Iran
City
Arak
Postal code
Phone
+98 86 3417 3502
Fax
Email
sh.amjadi@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)