Aim: to evaluate the efficacy of Cerebrolysin and the rate of nerve protection which arise by this drug in patients with acute ischemic brain attack. Method: 100 patients, aged 45-85 years, with cerebral ischemic attack will participate in the trial. They will be selected during the first 12 hours after symptoms of acute stroke. They should take routine treatment. They will be allocated to Cerebrolysin or placebo groups randomly. Intervention group will take Cerebrolysin 30 ml per day for 5 days in the first week and 10 ml per day for 5 days in the second, third and fourth weeks. Control group will take placebo in the same dose and duration. We quantify the improved dynamic time based on depletion neurologic finding and tendency to create and to help expedite the progress of recovery criteria: PGS (Patient Global Satisfaction Score), MRS (Modified Rankin Scale), CGIS (Clinical Global Impression Scale), Barthel Index, MMSE (Mini-Mental State Exam), NIHSS (National Institutes of Health Stroke Scale) in both groups during the 30-day evaluation period. Criteria of neurologic symptoms shall be evaluated during the injection sequence with specific and defined information obtained in the form of specific projects. Neurologic level and improved performance status will be evaluated before and 3 or 4, 7, 15 and 30 days after the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138803272042N1
Registration date:2009-08-29, 1388/06/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-08-29, 1388/06/07
Registrant information
Name
kurosh Gharagozli
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 7243
Email address
gharagoz@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Cobel Darou company on behalf of Ebewe Pharma
Expected recruitment start date
2009-08-23, 1388/06/01
Expected recruitment end date
2010-08-23, 1389/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Cerebrolysin in the treatment of acute ischemic stroke
Public title
The efficacy of Cerebrolysin in the treatment of acute ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients aged 45 to 85 years, the occurrence of acute cerebral ischemic attack (embolic or thrombotic), hospitalization during 12 hours of first symptoms of stroke, systolic blood pressure less than 200 and diastolic less than 100 mmHg
Exclusion Criteria: recovery of neurologic symptoms after 4 hours of attack, hemorrhagic stroke or the occurrence of stroke in vertebrobasilar system with blood pressure ≥200/100 mmHg, seizures, Papilledema or rising intracranial pressure (RICP), neck stiffness or symptoms of brain stimulation, the condition of consciousness stupor and coma (GCS ≤ 6), acute myocardial infarction, National Institutes of Health Stroke Scale (NIHSS) less than 7 and more than 24, hepatic or renal failure - heart failure, dementia initial appearance, acute infectious disease, doubt the Involvement in subsequent brain area (posterior circulation), pregnant women, symptoms of progressive neurologic defects, patients who are in other trials, patients received piracetam or calcium channel blockers (CCB), Patients who received r-TPA treatment during first 4 hours of symptoms
Age
From 45 years old to 85 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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences - next to the Taleghani Hospital - Evin
City
Tehran
Postal code
Approval date
2008-03-16, 1386/12/26
Ethics committee reference number
51
Health conditions studied
1
Description of health condition studied
Cerebral infarction
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Clinical evaluation of motor ability (speech and motor ability of patients)
Timepoint
daily
Method of measurement
MRS (Modified Rankin Scale), NIHSS (National Institutes of Health Stroke Scale)
Secondary outcomes
1
Description
Improvement in the understanding of patients during the treatment
Timepoint
On days 3, 7, 15 and 30
Method of measurement
Asessment of CGIS (Clinical Global Impression Scale), PGS (Patient Global Satisfaction Score) and MMSE (Mini-Mental State Exam) by neurologist
Intervention groups
1
Description
Intervention: Cerebrolysin (30 mg for first 5 days during the first week and 10 mg for first 5 days in the second, third and fourth weeks) adding to routine therapy
Category
Treatment - Drugs
2
Description
Control: placebo in the same dose of the intervention group
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Dr Kurosh Gharagozli
Street address
Kamali St.- South Kargar St.
City
Tehran
2
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Dr Nahid Beladimoghadam
Street address
Madani St.
City
Tehran
3
Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
Dr Abulfazle Hemati
Street address
Ghods Sq.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mohammad Rahmati
Street address
Next Taleghani Hospital - Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy, Shahid Beheshti University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Cobel Darou
Full name of responsible person
Memarian
Street address
39 Alvand Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cobel Darou
Proportion provided by this source
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr kurosh Gharagozli
Position
Associate Professor of Neurology
Other areas of specialty/work
Street address
Loghman Hakim hospital
City
Tehran
Postal code
13336
Phone
+98 21 5541 7243
Fax
Email
gharagoz@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Majid Gafarpour
Position
Professor
Other areas of specialty/work
Street address
Neurology Department - Imam Khomeini Hospital - Tohid sq.
City
Tehran
Postal code
Phone
+98 21 8876 1329
Fax
Email
ghafarpour@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mazyar Shojaie
Position
Assistant Professor of Neurology
Other areas of specialty/work
Street address
Loghman Hakim hospital
City
Tehran
Postal code
133339
Phone
+98 21 5541 7243
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)