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IRCT20190717044248N6 IRCT 2023-03-19 Kerman University of Medical Sciences Investigation of melatonin effect on outcome of moderate and severe diffuse axonal injury(DAI) in men admitted in Kerman Educational And Traputical Center Of Shahid Bahonar: changes in inflammatory, oxidant activity and injury factors Investigation of melatonin effect on the outcome of moderate and severe diffuse axonal injury(DAI) in men admitted in Kerman Educational And Traputical Center Of Shahid Bahonar: changes in inflammatory, oxidant activity and injury factors 2022-10-22 anticipated 70 Complete https://irct.ir/trial/65923 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 70 eligible people are randomly assigned using random allocation software with a ratio of 1 to 1 in two groups receiving melatonin and receiving placebo orally, Blinding description: The method of blinding: The patient, the nurse who delivers the medicine, and the physician or researcher who is responsible for evaluating GCS and other outcomes are unaware of the original nature or placebo of the medicine. 3 diffuse axonal injury. Intervention 1: Intervention group: including 35 participants with diffuse axonal injury, each patient received 3 mg of melatonin (Razak Company) manufactured in Iran upon admission time and from the day after the injury: once a day, two hours before Sleep at 10 pm (because after the trauma, the melatonin secretion cycle is disturbed and its secretion may be more during the day than night) and they receive it for 4 weeks. Intervention 2: Control group: Including 35 participants who consume a placebo in the same form and during the same period of time as the intervention group. 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 Failure to hold a joint meeting between the executives in this regard
public Alireza Ghaedamini
no. 3, banafsheh Ave, Afzalipour Town
Kerman Iran (Islamic Republic of) 7718146764 +98 34 3434 0454 alirezaghaedamini@gmail.com Kerman University of Medical Sciences scientific Alireza Ghaedamini
No. 3, Banafsheh Ave., Afzalipour Town
Kerman Iran (Islamic Republic of) 7718146764 +98 34 3434 0454 alirezaghaedamini@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Man Gender Age between 18 to 60 Moderate (GCS:9-12) and Sever (GCS≤9) diffuse axonal injury less than 4 hours from accident 18 years 60 years Male Brain death sepsis electrolyte disorders use of steroids need for surgery except neurosurgery personal dissatisfaction high blood pressure diabetes metabolic acidosis (bicarbonate below 12) liver trauma cancer depression cardiovascular risk factors Autoimmune diseases respiratory failure fractures severe hypothermia (temperature less than 35 degrees Celsius) S06.30 Unspecified focal traumatic brain injury Treatment - Drugs Placebo Intervention group: including 35 participants with diffuse axonal injury, each patient received 3 mg of melatonin (Razak Company) manufactured in Iran upon admission time and from the day after the injury: once a day, two hours before Sleep at 10 pm (because after the trauma, the melatonin secretion cycle is disturbed and its secretion may be more during the day than night) and they receive it for 4 weeks. Control group: Including 35 participants who consume a placebo in the same form and during the same period of time as the intervention group. GOSE:Standard leveling is obtained based on death, vegetative state, severe disability, low level, high level, and moderate level. Timepoint: Admit time, first month, third month and sixth month. Method of measurement: Extended- Glasgow Coma Scale. Measurement of dependence in motor and cognitive domains where a higher score is a sign of higher recovery or less damage. Timepoint: Admit time, first month, third month and sixth month. Method of measurement: The Functional Independence Measure Scale. Glasgow criteria is obtained based on language, verbal and motor responses. Timepoint: Admission and discharge time. Method of measurement: physical examination. IL-1β. Timepoint: 24 hours and one month after admission. Method of measurement: Using the relevant kit. Serum melatonin level. Timepoint: Twice a day in the first 24 hours after the injury, once every 12 hours, and twice on the fifteenth day after the injury, once every 12 hours, and twice on the last day of use, once every 12 hours (6 times in total). Method of measurement: Using the relevant kit. IL-10. Timepoint: 24 hours and one month after admission. Method of measurement: Using the relevant kit. IL6MDA. Timepoint: 24 hours and one month after admission. Method of measurement: Using the relevant kit. Pyridyl triazine. Timepoint: 24 hours and one month after admission. Method of measurement: Using the relevant kit. Nerve growth factor. Timepoint: 24 hours and one month after admission. Method of measurement: Using the relevant kit. Thiobarbituric acid. Timepoint: 24 hours and one month after admission. Method of measurement: Using the relevant kit. S100B-Protean. Timepoint: 24 hours and one month after admission. Method of measurement: Using the relevant kit. Kerman University of Medical Sciences Approved 2021-07-12 Ethics committee of Kerman University of Medical Sciences Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway Kerman Kerman Iran (Islamic Republic of)