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IRCT20120215009014N378 IRCT 2021-01-28 Hamedan University of Medical Sciences Effect of melatonin versus placebo on clinical outcomes in patients with ischemic stroke Effect of melatonin versus placebo on clinical outcomes in patients with ischemic stroke: a double-blind randomized clinical trial 2021-05-05 anticipated 66 Complete https://irct.ir/trial/53898 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group, Blinding description: The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind. 3 Acute ischemia stoke. Intervention 1: Intervention group: routine treatment plus melatonin tablets (made by Razak Pharmaceutical Co.) 20 mg daily for 5 days. Intervention 2: Control group: routine treatment plus placebo tablets including starch (made by School of Pharmacy, Shahid Beheshti University) 20 mg daily for 5 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 the approval of the financial supporting organization.
public Ensieh Rahmani Yeganeh
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 ncrahmani1995@gmail.com Hamedan University of Medical Sciences scientific Dr. Davood Ahmadi Moghadam
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 d.ahmadimoghadam@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Age:18 to 85 years old Acute ischemic stroke for the first time Occurrence of stroke within the past 24 hours Focal neurological disorder NIHSS score of at least 4 and at most 27 18 years 85 years Both Pregnancy or breastfeeding Acute or chronic intracranial hemorrhage or aneurism Any type of cognitive or behavioral disorder Concurrent inflammatory disease Taking any antioxidant combination in the last month Sensitivity to melatonin I67.82 Cerebral ischemia Treatment - Drugs Placebo Intervention group: routine treatment plus melatonin tablets (made by Razak Pharmaceutical Co.) 20 mg daily for 5 days Control group: routine treatment plus placebo tablets including starch (made by School of Pharmacy, Shahid Beheshti University) 20 mg daily for 5 days The severity of neurological function. Timepoint: Before the intervention and on the fifth day and one and three months after the intervention. Method of measurement: Using the National Institutes of Health Stroke (NIHSS) questionnaire and the modified Rankin Scale (mRS) questionnaire. Hamedan University of Medical Sciences Approved 2020-11-08 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)