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IRCT20210819052232N1 IRCT 2021-11-07 Esfahan University of Medical Sciences Effectiveness of Rivastigmine and Donepezil on cognitive disorders Evaluation of the effectiveness of Rivastigmine and Donepezil on cognitive disorders in patients with moderate stroke 2021-11-22 anticipated 165 Complete https://irct.ir/trial/59701 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random function of Excel software based on patient file number will be used for randomization. Patients with moderate concussion were included in the Excel program based on the file number and were divided into three groups of case, control and control based on the random button. There were three groups of 55 people in total. By entering the file number in Excel program, then the random number is selected from the data analysis command. This study has 3 groups that can be numbered from 1 to 3, respectively. We also want 55 people in each group. As a result, sequences 1 to 3 should be repeated 55 times each time. It is clear that the repetition of each number occurs once in each group, so select 1 for repeating each number and 55 for repeating the sequence. In this way, 165 units will be produced. 3 Cognitive disorder. Intervention 1: Intervention group: Rivastigmine is prescribed for one month at a dose of 1.5 mg and then the dose will be increased by 3.5 mg. This drug is prescribed for patients in this group for up to three months. Intervention 2: Intervention group: Donpezil is given at a dose of 5 mg for one month, after which the dose will be increased by 10 mg. This drug is prescribed for patients in this group for up to three months. Intervention 3: Control group: Patients are in the control group treated with placebo, which is very similar to the drug and receives up to three months later. 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 There is no more information
public Mehdi Shafiei
Isfahan University of Medical Sciences, Hezar Jarib St.,
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 Mehdishafiei82@gmail.com Esfahan University of Medical Sciences scientific Mehdi Shafiei
Al-Zahra hospital, Sofeh St.,Isfahan,Iran
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 Mehdishafiei82@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patient consent to enter the study Patients with moderate concussion with an GCS of 12-8. no limit no limit Both Consciousness coefficient greater than 12 History of any brain disorders in the patient Patients with Acetylcholinesterase contraindications G31.84 Mild cognitive impairment, so stated Rehabilitation Rehabilitation Rehabilitation Intervention group: Rivastigmine is prescribed for one month at a dose of 1.5 mg and then the dose will be increased by 3.5 mg. This drug is prescribed for patients in this group for up to three months Intervention group: Donpezil is given at a dose of 5 mg for one month, after which the dose will be increased by 10 mg. This drug is prescribed for patients in this group for up to three months. Control group: Patients are in the control group treated with placebo, which is very similar to the drug and receives up to three months later. Reduce cognitive impairment. Timepoint: After discharge and three months after. Method of measurement: MMSE, NUCog, Moca questionnaire. Esfahan University of Medical Sciences Approved 2021-08-01 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib St., Shiraz Gate Isfahan Isfehan Iran (Islamic Republic of)