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IRCT20130310012776N8 IRCT 2022-02-11 Shiraz University of Medical Sciences effect of Memoral on memory after TBI Effect of Memoral on the memory dysfunction after mild traumatic brain injury , a randomize clinical trial 2022-02-04 anticipated 94 Complete https://irct.ir/trial/61524 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Included patients will be allocated randomly into the experiment and placebo groups via the blocked randomization method. A trained research assistant will use blocked randomization with block sizes of 4 with an equal probability to enroll the eligible patients to the experiment group (group A) and placebo (group B). Regarding the size of block 4, we have six possible combinations of group assignments, including AABB, ABAB, BAAB, BABA, BBAA, and ABBA. At first, the assistant will select one of these arrangements randomly, and the four eligible admitted patients would be assigned accordingly in each block. We will repeat this process many times to include the eligible patients, Blinding description: Although the patients will be informed of our primary objectives, they won’t know which drugs/ placebo they will receive. Well-trained nurses will be recruited to give the medication/placebo to the patients. As the placebo's color, shape, and size were identical to our medications, their differentiations were only possible via a specific code imprinted on the bottles. 4 Memory impairment after mild brain injury. Intervention 1: Intervention group: memoral capsules are given to patients every 8 hours at 8 am, 2 pm and 12 pm for one month. Intervention 2: Control group: placebo are given to patients every 8 hours at 8 am, 2 pm and 12 pm for one month. Yes - There is a plan to make this available What will be shared: The results of the memory test will be published after the completion of the necessary tests while maintaining the principle of anonymity of the patients When: The data will be availableafter the results are published To whom: Members of Trauma Research Center, Shiraz University of Medical Sciences Conditions: For possible use in future research, it will be made available to researchers with an approved researches Where to obtain: Emtiaz Hospital Trauma Research Center How to obtain: The researcher's request will be reviewed after sending an official letter to the Trauma Center Research Council Comments:
public Hosseinali Khalili
Rajaee Hospital, Chamran Boulevard, Shiraz, Iran.
Shiraz Iran (Islamic Republic of) ۷۱۹۴۸۱۵۷۱۱ +98 71 3625 4206 khalili_h@sums.ac.ir Shiraz University of Medical Sciences scientific Hosseinali Khalili
Rajaee Hospital, Chamran Boulevard, Shiraz, Iran.
Shiraz Iran (Islamic Republic of) 7194815711 +98 71 3625 4206 khalili_h@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Cases should have mild traumatic brain injury cases should have memory dysfunction after MTBI age between 20 and 60 years at least six class of education 20 years 60 years Both moderate or severe brain injury history of psychiatric or neurological disorders history of hematologic disorders Having previous history of trauma Having major psychiatric and neurologic disorders according to the self-report S07.1 Crushing injury of skull Treatment - Drugs Placebo Intervention group: memoral capsules are given to patients every 8 hours at 8 am, 2 pm and 12 pm for one month. Control group: placebo are given to patients every 8 hours at 8 am, 2 pm and 12 pm for one month. Patient memory function. Timepoint: Intervals of one month and three months after starting the drug. Method of measurement: Based on the auditory-verbal learning test questionnaire (AVLT). Shiraz University of Medical Sciences Approved 2022-01-10 Ethics committee of Shiraz University of Medical Sciences Zand Boulevard, the central building of Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)