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IRCT20231220060484N1 IRCT 2023-12-27 Islamic Azad University Protective effect of Melatonin on clinical outcomes in patients with acute ischemic stroke Evaluation of the Effect of Melatonin on Clinical Outcomes in Patients with Acute Ischemic Stroke: a Randomized Double-Blind Placebo-Controlled Clinical Trial 2023-12-19 anticipated 70 Complete https://irct.ir/trial/74574 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The blocking process has two stages. In the first stage, the samples with entry criteria are selected by census and in the second stage, the block method will be used for randomization. Blocking process will be done with a random allocation software and the size of the blocks are predicted to be in four. As a result, the number of blocks will be equal to 18. After obtaining informed consent, as predicted by the software the samples are entered in one of A or B groups. Also in order to avoid from identification of A and B groups, instead of A or B labels each participant will be assigned by a random 4-digit code obtained from the computer, 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 stroke. Intervention 1: Intervention group: routine treatment plus melatonin tablets (made by Jalinus Pharmaceutical Co.) 10 mg daily for 5 days. Intervention 2: Control group: routine treatment plus placebo tablets including starch (made by Jalinus Pharmaceutical Co. ) 10 mg daily for 5 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no plan for publishing the protocol of study because it is accessible in IRCT
public Amirhossein Ghanbarzamani
No. 99, Yakhchal street, Dr Shariati Ave.
Tehran Iran (Islamic Republic of) 1941933111 +98 21 2264 0056 amirh.ghzamani@gmail.com Islamic Azad University scientific Amirhossein Ghanbarzamani
No. 99, Yakhchal street, Dr Shariati Ave.
Tehran Iran (Islamic Republic of) 1941933111 +98 21 2264 0056 amirh.ghzamani@gmail.com Islamic Azad University Iran (Islamic Republic of) Age:18 to 85 years old Occurrence of stroke within the past 24 hours NIHSS score of at least 4 and at most 27 Not eligible for thrombolytic therapy and thrombectomy 18 years 90 years Both Pregnancy or breastfeeding Acute or chronic intracranial hemorrhage or aneurism Any type of cognitive or behavioral disorder Concurrent inflammatory disease and/or malignancy Patients with transient ischemic attacks Sensitivity to Melatonin I67.82 Cerebral ischemia Treatment - Drugs Placebo Intervention group: routine treatment plus melatonin tablets (made by Jalinus Pharmaceutical Co.) 10 mg daily for 5 days Control group: routine treatment plus placebo tablets including starch (made by Jalinus Pharmaceutical Co. ) 10 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. Islamic Azad University Approved 2023-12-12 Ethics Committee of Department of Pharmaceutical Sciences,Tehran Islamic Azad University of Medical Islamic Azad University of Pharmaceutical Sciences Branch, Yakhchal Ave., Gholhak, Dr Shariati Ave. Tehran Tehran Iran (Islamic Republic of)