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IRCT201601289014N90 IRCT 2016-02-24 Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Effect of citicoline versus placebo on clinical signs in patients with acute ischemic and hemorrhagic stroke Effect of citicoline versus placebo on clinical signs in patients with acute ischemic and hemorrhagic stroke: a triple blind control trial 2016-02-20 anticipated 160 Complete https://irct.ir/trial/9528 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization: The patients will be randomly assigned to intervention and control groups using block randomization of 4 group. Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind. 2 stroke. Intervention 1: Intervention group: Infusion of citicoline 1 gr in normal saline (overall 20 ml) once daily for 10 days. Intervention 2: Control group: Infusion of 20 ml normal saline once daily for 10 days.
public Dr Shahir Mazaheri
Sina Hospital, Mirzadeh Eshghi Ave.
Hamadan Iran (Islamic Republic of) +98 81 3827 4184 sh.mazaheri@umsha.ac.ir Sina Hospital scientific Dr Shahir Mazaheri
Sina Hospital, Mirzadeh Eshghi Ave.
Hamadan Iran (Islamic Republic of) +98 81 3827 4184 sh.mazaheri@umsha.ac.ir Sina Hospital Iran (Islamic Republic of) Inclusion criteria: (a) age of 18 to 85 years; (b) acute stroke; (c) NIHSS score between 6 to 22. Exclusion criteria: (a) previous history of stroke; (b) renal or liver failure; (c) cancer; (d) active infectious disease during last month; (e) trauma or surgery during last month; (f) history of collagen vascular disease; (g) immunosuppressive medications or corticosteroid; (h) signs of brain hernia; (i) convulsion at the time of stroke; (j) neurologic disease or dementia; (k) pregnancy or breastfeeding; (l) receiving vasodilator medications. 18 years 85 years Both I64 Stroke, not specified as haemorrhage or infarction Treatment - Drugs Placebo Intervention group: Infusion of citicoline 1 gr in normal saline (overall 20 ml) once daily for 10 days Control group: Infusion of 20 ml normal saline once daily for 10 days Measuring stroke score (NIHSS ). Timepoint: at baseline and 10 and 90 days after intervention. Method of measurement: based on NIHSS. Measuring stroke score (Barthel Index). Timepoint: at baseline and 10 and 90 days after intervention. Method of measurement: based on Barthel Index. Measuring stroke score (Modified Rankin Scale). Timepoint: at baseline and 10 and 90 days after intervention. Method of measurement: based on Modified Rankin Scale. Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Approved 2016-01-23 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Iran (Islamic Republic of)