Objectives: To assess the effect of cerebrolysin versus placebo on improvement of patients with acute ischemic stroke.
Design: A double blinded randomized clinical trial.
Setting and conduct: All eligible patients with acute ischemic stroke who will refer to clinic of Farshchian Hospital will be enrolled in to the trial.
Inclusion criteria: (a) having ischemic stroke; (b) age of 40 to 85 years; (c) referring the patient within less than 24 hours after stroke.
Exclusion criteria: (a) being in coma; (b) having systolic blood pressure above 240 mmHg or diastolic blood pressure above 120 mmHg; (c) history of myocardial infarction or heart failure; (d) history of renal failure; (e) history of liver failure; (f) having severe dementia.
Intervention: Routine treatment of ischemic stroke plus intravenous infusion of cerebrolysin 10 ml in 100 ml normal saline daily for 7 days.
Control: Routine treatment of ischemic stroke plus intravenous infusion of 100 ml normal saline alone daily for 7 days.
Primary outcome: measuring motor function using Canadian Stroke Scale before intervention and 3 and 7 days after intervention.
Secondary outcome: (a) measuring motor function using Madified Ranking Scale one month after intervention; (b) measuring motor function using Bartel Index one month after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201406169014N36
Registration date:2014-06-23, 1393/04/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-23, 1393/04/02
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2014-06-21, 1393/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cerebrolysin versus placebo on improvement of patients with acute ischemic stroke: a double blinded randomized clinical trial
Public title
The effect of cerebrolysin versus placebo on improvement of patients with acute ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) having ischemic stroke; (b) age of 40 to 85 years; (c) referring the patient within less than 24 hours after stroke.
Exclusion criteria: (a) being in coma; (b) having systolic blood pressure above 240 mmHg or diastolic blood pressure above 120 mmHg; (c) history of myocardial infarction or heart failure; (d) history of renal failure; (e) history of liver failure; (f) having severe dementia.
Age
From 40 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
122
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: A systematic random allocation method is used so that the patients who referred to the first specialist were assigned to the intervention group and the patients who referred to the second specialist were assigned to the control group.
Blinding: All patients received the same intravenous treatment with different context. Thus they were unaware of the type of intervention. In addition, the physician who examined the patients was not aware of the intervention. Therefore, the trial was run as double blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2014-05-17, 1393/02/27
Ethics committee reference number
P/16/35/9/705
Health conditions studied
1
Description of health condition studied
Ichemic stroke
ICD-10 code
I63
ICD-10 code description
cerebral infarction
Primary outcomes
1
Description
measuring motor function
Timepoint
before intervention and 3 and 7 days after intervention
Method of measurement
using Canadian Stroke Scale
Secondary outcomes
1
Description
measuring motor function
Timepoint
one month after intervention
Method of measurement
using Madified Ranking Scale
2
Description
measuring motor function
Timepoint
one month after intervention
Method of measurement
using Bartel Index
Intervention groups
1
Description
Routine treatment of ischemic stroke plus intravenous infusion of cerebrolysin 10 ml in 100 ml normal saline daily for 7 days
Category
Treatment - Drugs
2
Description
Routine treatment of ischemic stroke plus intravenous infusion of 100 ml normal saline alone daily for 7 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Sajedeh Nazari
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Farshchian Hospital
Full name of responsible person
Sajedeh Nazari
Position
Medical Student
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Postal code
Phone
+98 81 3264 0021
Fax
Email
sajed_nazari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Farshchian Hospital
Full name of responsible person
Dr Mehrdokht Mazdeh
Position
Neurologist
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Postal code
Phone
+98 81 3264 0021
Fax
Email
mehrdokhtmazdeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)