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IRCT138803272042N1 IRCT 2009-08-29 Research Deputy, Shahid Beheshti University of Medical Sciences The efficacy of Cerebrolysin in the treatment of acute ischemic stroke The efficacy of Cerebrolysin in the treatment of acute ischemic stroke 2009-08-23 anticipated 100 Complete https://irct.ir/trial/1663 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 3 Cerebral infarction. Intervention 1: 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. Intervention 2: Control: placebo in the same dose of the intervention group.
public Dr kurosh Gharagozli
Loghman Hakim hospital
Tehran Iran (Islamic Republic of) 13336 +98 21 5541 7243 gharagoz@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Dr. Majid Gafarpour
Neurology Department - Imam Khomeini Hospital - Tohid sq.
Tehran Iran (Islamic Republic of) +98 21 8876 1329 ghafarpour@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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 45 years 85 years Both I63 Cerebral infarction Treatment - Drugs 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 Control: placebo in the same dose of the intervention group 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). 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. Cobel Darou Research Deputy, Shahid Beheshti University of Medical Sciences Cobel Darou Approved 2008-03-16 Ethics Committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences - next to the Taleghani Hospital - Evin Tehran Iran (Islamic Republic of)