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IRCT20191104045328N6 IRCT 2021-04-30 Arak University of Medical Sciences Evaluation of the effect of riluzole in improving the condition of patients with severe traumatic brain injury Evaluation of Riluzole efficacy on cognitive and functional outcome of severe traumatic brain injury patients 2021-05-05 anticipated 50 Complete https://irct.ir/trial/55278 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants are assigned to two intervention and control groups, respectively, based on the randomization sequence that will be generated beforehand. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 8 blocks will be used to allocate samples. Thus, using block numerical random number generation software, a randomization sequence proportional to the sample size required for the two groups will be generated. Initially, all cases in which the two letters A and B can be arranged in blocks of 8 are produced. A block is then randomly selected from the blocks and the layout pattern in that block will be used to assign participants. This block will then be placed in the main container and another block will be selected again. All this will be done with software called Sealed Envelope. With this method, concealment will also be observed. The concept of concealment is to unpredictably assign individuals to groups. In fact, the researcher will not be able to predict which group the next person will be in, Blinding description: In the process of blinding, the treating physician and the patient are blind and the trained assistant is in the process of studying. The person completing the questionnaire is the same trained assistant or facilitator. 3 Traumatic brain injury. Intervention 1: Intervention group: The treatment protocol includes administration of the drug (riluzole) for 2 weeks, at a dose of 500 mg every 12 hours, preferably during the first 12 hours after trauma and at the first opportunity after the ability to eat by mouth. Intervention 2: Control group: Distilled water is administered for 2 weeks every 12 hours, preferably during the first 12 hours after trauma and at the first opportunity after the ability to eat by mouth. Yes - There is a plan to make this available What will be shared: After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study. When: Access will be from 2022/4/20 to 2026/4/20 for 4 years. To whom: University researchers Conditions: If there are any further questions Where to obtain: Dr Aidin Shakeri How to obtain: Letter writing should be done with professors and universities. Comments:
public Dr Mohsen Dalvandi
Vali Asr hospital, Shahid Shiroudi Street, Arak, Iran
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 dalvandi@arakmua.ac.ir Arak University of Medical Sciences scientific Dr Aidin Shakeri
Vali Asr hospital, Shahid Shiroudi Street, Arak, Iran
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 amin.medstu@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Patients with severe traumatic brain injury Impenetrable brain injury Age over 16 years Ability to receive medication through the mouth or nasogastric tube Glasgow Coma Scale (GCS) less than 9 Having informed consent by family members primarily to participate in the study 16 years 60 years Both Kidney and liver failure History of severe brain injury (tumor or stroke) Unidentifiable patients Pregnancy S06.2 Diffuse traumatic brain injury Treatment - Drugs Placebo Intervention group: The treatment protocol includes administration of the drug (riluzole) for 2 weeks, at a dose of 500 mg every 12 hours, preferably during the first 12 hours after trauma and at the first opportunity after the ability to eat by mouth. Control group: Distilled water is administered for 2 weeks every 12 hours, preferably during the first 12 hours after trauma and at the first opportunity after the ability to eat by mouth. Glasgow Coma Scale. Timepoint: Upon arrival of the patient, after initial resuscitation, third day, seventh day. Method of measurement: Glasgow Coma Scale Checklist. 4 score. Timepoint: Upon arrival of the patient, after initial resuscitation, third day, seventh day day. Method of measurement: 4 score checklist. Glasgow outcome scale. Timepoint: First month after intervention, Sixth month after intervention. Method of measurement: glasgow outcome scale checklist. Karnovsky performance status. Timepoint: First month after intervention, Sixth month after intervention. Method of measurement: Karnovsky performance status checklist. Mini Mental State Test. Timepoint: First month after intervention, Sixth month after intervention. Method of measurement: Mini Mental State Test. Disability Rating Scale. Timepoint: First month after intervention, Sixth month after intervention. Method of measurement: Disability Rating Scale. Arak University of Medical Sciences Approved 2020-09-06 Ethics Committee of Arak University of Medical Sciences Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran Arak Markazi Iran (Islamic Republic of)