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IRCT20120215009014N215 IRCT 2018-03-19 Hamedan University of Medical Sciences Effect of high-dose oral N-acetylcysteine versus placebo on serum level of inflammatory cytokines in patients with ischemic stroke Effect of high-dose oral N-acetylcysteine versus placebo on serum level of inflammatory cytokines in patients with ischemic stroke: a double-blind randomized clinical trial 2018-04-20 anticipated 100 Complete https://irct.ir/trial/30005 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly assigned to intervention and control groups using block randomization, Blinding description: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double-blind. 2 Ischemic stroke. Intervention 1: Intervention group: Routine stroke treatment plus oral N-acetylcysteine tablet (manufactured by Hexal Pharmaceutical Co.) with a loading dose of 4 g and then 2 g every 12 hours for 2 days. Intervention 2: Control group: Routine stroke treatment plus placebo tablet (manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) with a loading dose of two tablets and then one placebo tablet every 12 hours for 2 days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It depends on the situations and the results of the study as well as approval of the financial supporting organization.
public Dr. Maryam Mehrpoya
Sina Hospital, Mirzadeh Eshghi Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3827 4184 m_mehrpooya2003@yahoo.com Hamedan University of Medical Sciences scientific Dr. Mehrdokht Mazdeh
Sina Hospital, Mirzadeh Eshghi Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3827 4184 mehrdokhtmazdeh@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age of 18 to 85 years Ischemic stroke Stroke for the first time Local neurologic disorder Hospitalization within the first 24 hours after stroke 18 years 85 years Both Pregnancy or breastfeeding Inflammatory disease Asthma A history of anaphylaxis shock I63 Cerebral infarction Treatment - Drugs Placebo Intervention group: Routine stroke treatment plus oral N-acetylcysteine tablet (manufactured by Hexal Pharmaceutical Co.) with a loading dose of 4 g and then 2 g every 12 hours for 2 days Control group: Routine stroke treatment plus placebo tablet (manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) with a loading dose of two tablets and then one placebo tablet every 12 hours for 2 days Measuring serum level of TNF-α. Timepoint: Before intervention and 3 days later. Method of measurement: Through laboratory test. Measuring serum level of IL-6. Timepoint: Before intervention and 3 days later. Method of measurement: Through laboratory test. Measuring serum level of ICAM-1. Timepoint: Before intervention and 3 days later. Method of measurement: Through laboratory test. Measuring serum level of NSE. Timepoint: Before intervention and 3 days later. Method of measurement: Through laboratory test. Hamedan University of Medical Sciences Approved 2018-02-24 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)