Investigation the effectiveness and non-effectiveness of Resveratrol neuroprotective material during acute phase of ischemic stroke on neurologic deficiency
This study will be done with aim to investigate the effectiveness of Resveratrol
neuroprotective material during acute phase of ischemic stroke on neurologic deficiency. This study is a double blind clinical trial. The study population will be included patients with ischemic stroke referring to Imam Reza Hospital.
100 eligible patients will be selected in available method and randomly based on randomized block alternatives will be assigned to two intervention and control groups. Stroke routine treatments will be applied to both groups. The intervention group, in addition to routine stroke treatments, will receive Resveratrol 500 mg daily for 30 days. The control group, in addition to routine stroke treatments, will receive 500 mg of placebo daily for 30 days in the form of powdered capsules. Before starting treatment and time of discharge NIHSS will be measured. The Barthel and MRS tests will be conducted three months later by phone and the effect of Resveratrol on average of blood pressure as well as in different age groups and both sexes are evaluated.
Inclusion criteria: Age between 45 and 90 years; Diagnosis of ischemic stroke in MCA territory
Exclusion criteria: Pregnancy; Referral of the patient for more than 24 hours after start of symptoms; Patients who have received RtPA; Brain hemorrhage and previous stroke.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061328430N1
Registration date:2017-09-09, 1396/06/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-09-09, 1396/06/18
Registrant information
Name
Payam Sariaslani
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3835 4434
Email address
psariaslani@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-09-11, 1396/06/20
Expected recruitment end date
2018-01-10, 1396/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effectiveness and non-effectiveness of Resveratrol neuroprotective material during acute phase of ischemic stroke on neurologic deficiency
Public title
Evaluation of neuroprotective effect of Resveratrol during acute ischemic stroke on neurologic deficit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 45 and 90 years; Diagnosis of ischemic stroke in MCA territory
Exclusion criteria: Pregnancy; Referral of the patient for more than 24 hours after start of symptoms; Patients who have received RtPA; Brain hemorrhage and previous stroke.
Age
From 45 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomized method based on randomized block alternatives
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Blvd
City
Kermanshah
Postal code
Approval date
2017-01-25, 1395/11/06
Ethics committee reference number
kums.rec.1395.647
Health conditions studied
1
Description of health condition studied
Ischemic stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Blood pressure
Timepoint
Before the start of the study, upon discharge and three months after the discharge
Method of measurement
Using the barometer device
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group, in addition to routine stroke treatments, will receive Resveratrol 500 mg daily for 30 days.
Category
Treatment - Drugs
2
Description
Treatment: drugs Treatment: drugs
The control group, in addition to routine stroke treatments, will receive 500 mg of placebo daily for 30 days in the form of powdered capsules.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. Sajedeh Asgharzadeh
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshh
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Blvd
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Sajedeh asgharzadeh
Position
Resident of Neurology
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6301
Fax
Email
s.asgharzadeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Payam Sariaslani
Position
Neurologist
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6301
Fax
Email
psariaslani@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Sajedeh Asgharzadeh
Position
Resident of Neurology
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Blvd
City
Kermanshah
Postal code
Phone
+98 83 3427 6301
Fax
Email
s.asgharzadeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)