]>
IRCT20190804044429N10 IRCT 2023-01-22 Mazandaran University of Medical Sciences Melatonin ischemic stroke The effects of melatonin on oxidative pathways in patients with acute ischemic stroke: A randomized double-blind clinical trial 2023-01-21 anticipated 60 Complete https://irct.ir/trial/68011 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization using the block method by a person who is not related to the study. Packages containing the drug and placebo are completely similar in shape and color. Randomization of serial numbers of drug packages and placebo by a person who is not involved in the project according to randomized table. The number of the bottle corresponded with the number of the patient. Random block method will be used to allocate the samples to two groups. Blocks will be considered as 4 blocks and in each block of 4 people, two people in the intervention group and two people in the control group will be selected. The selection of the order type in each group for each person will be done through second version of random allocation software, Blinding description: This study is double_ blind. Outcome elevator and participant are blinded (double blind) and aware from grouping (intervention or placebo). 2-3 Cerebellar stroke syndrome. Intervention 1: Intervention group: patients in the intervention group will receive 30 mg melatonin following acute ischemic stroke for 5 days. Intervention 2: Control group: patients in the control group will receive a placebo in the form of tablets with the same color, size and packaging as the intervention group and without the active pharmaceutical ingredient for five days. Yes - There is a plan to make this available What will be shared: Data related to the initial outcoms of the study will be shared When: The data will be available one year after publication To whom: Academic reseachers, medical team and scientific institutes Conditions: Requests for sharing data should be sent to the person responsible for general inquiries Where to obtain: Requests for sharing data should be sent to the person responsible for general inquiries. Ghazaeianm@gmail.com How to obtain: Person in charge of scientific study will reply to the request within 10 days Comments:
public Mazandaran University of Medical Sciences
Ibn Sina hospital, Pasdaran Blvd, Sari, Mazandaran province, Iran
Sari Iran (Islamic Republic of) 4815733971 +98 33343011 Ghazaeianm@gmail.com Mazandaran University of Medical Sciences scientific Monireh Ghazaeian
Ibn Sina hospital, Pasdaran Blvd, Sari, Mazandaran province, Iran
Sari Iran (Islamic Republic of) 4815733971 +98 11 3334 3011 Ghazaeianm@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Adults over the age of 18 and diagnose with acute ischemic stroke according to brain CT scan findings NIHSS more than 4 18 years no limit Both Hemorrhagic stroke Lacunar infarct TIA NIHSS more than 25 Pregnancy Lactation Severe hepatic insufficiency History of apnea G46.4 Cerebellar stroke syndrome Treatment - Drugs Placebo Intervention group: patients in the intervention group will receive 30 mg melatonin following acute ischemic stroke for 5 days Control group: patients in the control group will receive a placebo in the form of tablets with the same color, size and packaging as the intervention group and without the active pharmaceutical ingredient for five days Glutathione serum level. Timepoint: days 0 and 5th of the study. Method of measurement: Spectroscopy. Antioxidant serum levels. Timepoint: at days 0 and 5th of the study. Method of measurement: Spectroscopy. Disability following stroke. Timepoint: At days 0, discharge and month three of the study. Method of measurement: According to mRS. Tolerability of melatonin. Timepoint: During the study period. Method of measurement: History taking. Mazandaran University of Medical Sciences Approved 2022-08-10 Mazandaran university of medical Sciences Ibn Sina hospital, Pasdaran Blvd Sari Mazandaran Iran (Islamic Republic of)