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IRCT20210602051472N1 IRCT 2021-06-20 Hamedan University of Medical Sciences Evaluation of the Edaravan Effect on the outcomes ain patients with acute ischemic stroke Evaluation of the Edaravan Effect on the outcomes and oxidative stress parameters in patients with acute ischemic stroke: a clinical trial study 2021-07-23 anticipated 60 Complete https://irct.ir/trial/56723 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For this purpose, we will use the quadruple block method (Block Randomization). For this purpose, we prepare four sheets of paper. On the two sheets we write the letter I meaning "Intervention" and on the two sheets the letter S means "Standard treatment". Mix the sheets together and place them in the desk drawer. With the referral of each eligible patient, one of the sheets will be randomly taken out and based on this extracted sheet will be assigned to one of the two intervention groups. It should be noted that the pulled out sheets will not be returned to the drawer until all four sheets have been pulled out. After randomly pulling out all four sheets, all sheets are returned to the drawer and the above procedure will be continued for the next four patients until the desired sample size is reached, Blinding description: Given that the patient and the researcher will be unaware of the type of drug used. Therefore, the study will be conducted in a double-blind manner. 2 acute ischemic stroke. Intervention 1: Intervention group: In this group, in addition to standard treatment, a dose of Edaravan (Zist daroo danesh Company) starts with a dose of 0.16 ml per weight and continues with a dose of 4.4 ml per hour per hour and continues for three days. The method of choice is to inject 360 mg of Edaravan into the intervention group over three days, which is 120 mg daily, and the injection method is by infusion. Intervention 2: Standard treatment group: This group receives pharmacological treatment (anti-platelet including aspirin 80 mg daily and thrombolysis including altplase at a dose of 0.9 mg per body weight) and standard care plus placebo at the same time as the intervention group. Yes - There is a plan to make this available What will be shared: Individual data of study participants can be shared after identifying individuals When: Access period starts 6 months after the results are published To whom: For all researchers who send an email request to the author of the article. Conditions: In addition to the above conditions, researchers who intend to study clinically in addition to the drug mentioned are allowed to submit a request for unidentified individual data. Where to obtain: Responsible people including the corresponding author of the article or the scientific person in charge of the intervention: Dr.Mojtaba Khazaei; Neurologist and Assistant Professor. To the address of Hamadan city - Shahid Fahmideh Blvd- Hamadan University of Medical Sciences Postal code 6516618697 Phone +98 81 3838 0030 Mobile +98 918 150 1628 email khazaeimajtaba@yahoo.com. How to obtain: After obtaining the necessary permits from the Deputy Minister of Research and Technology, it will take about a month. Comments: Vice-Chancellor for Research and Technology of Hamadan University of Medical Sciences Postal code 6517838678 Phone +98 81 3838 0267 email Shirin.sharifi@umsha.ac.ir
public Fatemeh Saadatipour
Fahmideh Blvd, Pajoohesh Sq, Hamadan
hamadan Iran (Islamic Republic of) 6516618697 +98 81 3838 0030 Dr.fatemehsaadatypour@gmail.com Hamedan University of Medical Sciences scientific Mojtaba Khazaei
Fahmideh Blvd, Pajoohesh Sq, Hamadan
Hamadan Iran (Islamic Republic of) 6516618697 +98 81 3838 0030 khazaeimajtaba@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Focal neurological symptoms due to cerebrovascular involvement in less than 24 hours Older age 18 years Stroke is approved by CT or MRI. The severity of the stroke should be greater than 4 by the NIHSS criteria and the patient's ability scale before the stroke should be less than 2. It should be noted that it is also injected at intensities higher than 24. The patient is inclined to enter the study 18 years no limit Both Hemorrhagic stroke Transient stroke Brain Tumor Inflammatory diseases and demyelinating brain History of craniotomy Previous severe brain trauma Liver and kidney failure Pregnancy and lactation Acute heart attack Allergy to the drug Adaravan I63 Cerebral infarction Other Treatment - Drugs Intervention group: In this group, in addition to standard treatment, a dose of Edaravan (Zist daroo danesh Company) starts with a dose of 0.16 ml per weight and continues with a dose of 4.4 ml per hour per hour and continues for three days. The method of choice is to inject 360 mg of Edaravan into the intervention group over three days, which is 120 mg daily, and the injection method is by infusion. Standard treatment group: This group receives pharmacological treatment (anti-platelet including aspirin 80 mg daily and thrombolysis including altplase at a dose of 0.9 mg per body weight) and standard care plus placebo at the same time as the intervention group. Modified Rankin Score (MRS). Timepoint: At the time of discharge and three months after the intervention. Method of measurement: The ability of patients, which is mainly assessed after 90 days by checklist. NIH Stroke Scale/Score (NIHSS). Timepoint: At the time of discharge and three months after the intervention. Method of measurement: check list. ESR measurement. Timepoint: At the time of discharge and three months after the intervention. Method of measurement: Blood Samples, Green Blot Method. CRP Measurement. Timepoint: At the time of discharge and three months after the intervention. Method of measurement: Blood Samples, Immuno-agglutination Assay. Side effects of treatment. Timepoint: After discharge and three months after intervention. Method of measurement: checklist. Hamedan University of Medical Sciences Approved 2021-04-10 دانشگاه علوم پزشکی همدان Fahmideh Blvd, Pajoohesh Square, Hamadan University of Medical Sciences, Hamadan Town همدان Hamadan Iran (Islamic Republic of)