Effect of citicoline versus placebo on clinical signs in patients with acute ischemic and hemorrhagic stroke: a triple blind control trial

Objectives: To assess the effect of citicoline versus placebo on clinical signs in patients with acute ischemic and hemorrhagic stroke Design: a triple blind randomized clinical trial. Setting and conduct: The eligible patients with acute ischemic and hemorrhagic stroke who will refer to Sina Hospital during the study period will be enrolled into the trial. 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. 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 Primary outcome: (a) measuring stroke score based on NIHSS at baseline and 10 and 90 days after intervention; (b) measuring stroke score based on Barthel Index at baseline and 10 and 90 days after intervention; (c) Measuring stroke score based on Modified Rankin Scale at baseline and 10 and 90 days after intervention. Secondary outcome: Nothing. 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.

Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences