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IRCT20100107003014N25 IRCT 2021-09-19 Mazandaran University of Medical Sciences Comparison of the effect of memantine on NSE and GCS among traumatic brain injury patients Comparison of the effect of memantine and placebo on NSE and GCS of traumatic brain injury patients: a randomized double blind, placebo controlled clinical trial 2020-07-22 anticipated 60 Complete https://irct.ir/trial/49642 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: Considering the inclusion criteria, 60 eligible samples will be selected by available sampling method.The process of random allocation of patients will be done by blocking with random allocation software at the address: https://random-allocation-software.software.informer.com/2.0/. The number of 15 quadruple blocks will be determined with the help of software. Participants will be randomly assigned to the study groups according to block randomization with 4 patients in each block, Blinding description: Participating patients, principal investigator (supervisor and assistant), healthcare staff (physicians, nurses), data collection assistant, and those evaluating the outcome are unaware of the type of intervention being assigned. The appearance and packaging of the drug and placebo are similar. N/A Traumatic brain injury. Intervention 1: Intervention group1: 30 mg tablet Memantine , twice daily until one week. Intervention 2: Control group: Placebo, 30 mg tablet, twice daily until one week. 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 for uncertain capability of gathering traumatic brain injury patients because of COVID-19
public Shahram Ala
Faculty of Pharmacy, Payambar Azam University Complex -18th km of Farahabad road
Sari Iran (Islamic Republic of) 4847193698 +98 11 3354 3081 sala@mazums.ac.ir Mazandaran University of Medical Sciences scientific Shahram Ala
Faculty of Pharmacy, Payambar Azam University Complex -18th km of Farahabad road
Sari Iran (Islamic Republic of) 4847193698 +98 11 3354 3081 sala@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Traumatic brain injury (TBI) Glasgow Coma Scale (GCS) between 6-12 Being at the age of 18 years old and above The patient can tolerate the drug in the first 24 hours after traumatic brain injury 18 years no limit Both Diabetes mellitus, uncontrolled (random blood sugar greater than 200 mg / dL at the time of administration) Acute myocardial infarction in the last 48 hours Acute or chronic renal failure, creatinine clearance less than 60 ml per minute Autoimmune disorders and malignant diseases S06 Intracranial injury Treatment - Drugs Placebo Intervention group1: 30 mg tablet Memantine , twice daily until one week Control group: Placebo, 30 mg tablet, twice daily until one week Neuron-specific enzyme (NSE). Timepoint: Days 1, 3 and 7. Method of measurement: Laboratory test. Glasgow coma scale. Timepoint: Days 1, 3 and 7. Method of measurement: clinical. Survival / Death. Timepoint: 3 months later. Method of measurement: Phone call with patient. Mazandaran University of Medical Sciences Approved 2020-07-08 Ethics committee of Mazandaran University of Medical Sciences Faculty of Pharmacy, Payambar Azam University Complex, Farahabad Road Sari Mazandaran Iran (Islamic Republic of)