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IRCT20210816052203N1 IRCT 2021-08-24 Artesh University of Medical Sciences The effect of Donepezil on memory impairment after Covid-19 Evaluation of the effect of Donepezil Hydrochloride on memory impairment in patients recovered from Covid-19 with hospitalization history in comparison with the control group 2021-09-01 anticipated 70 Complete https://irct.ir/trial/58179 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into case groups (drug recipient) and control group with simple random method by using the random number table. The random number function was used to randomize and assign individuals to groups; Randomization using Excel software is as follows: First, in a column, the groups are entered as A, B and below each other; because the number of samples in each group is set to 35 (taking into account the sample loss), 35 A and 35 B must be entered in order and below each other. In the opposite column, random numbers are generated using the RAND command. In the next step, with using the sort command, random numbers are generated from small to large or vice versa, which causes the order of the groups A and B to be changed. In fact, using the new order, individuals are randomly assigned to the case and control groups, Blinding description: This study is a single blind that data analyzer, who is a consultant professor in statistics, meantime she is aware of the general objectives of the research, she is kept blind, in such a way that meantime each participant is assigned a code and participants are informed about the study process and how to assign groups, are classified randomly with using the table of random numbers in the case and control groups. The statistics counselor is informed about the objectives and general process of the research, but in order to prevent her possible bias in analyzing the data, the code of the control group and the case group is not mentioned and she is informed at the end of the study. 3 Memory impairment due to Post acute COVID-19 syndrome (LONG-Covid Syndrome). Intervention 1: Intervention group: This group is treated with Donepezil Hydrochloride with the brand name Aricept at a dose of 5 mg (half a tablet for the first 5 nights and then one tablet overnight for 3 months and from 3 months to 6 months after starting the drug are reached the dose10 mg daily). This drug is FDA-APPROVED for the treatment of Alzheimer's disease and is currently routinely prescribed in Iran. Intervention 2: Control group: This group is not face to special intervention and is examined in parallel with the case group in terms of memory indexes. 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 Sakhabakhsh
Khanevadeh Hospital of AJA University of Medical Sciences, Kaj Avenue, Shariati Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 16139-16411 +98 21 7750 7512 drsakha2013@gmail.com Artesh University of Medical Sciences scientific Mehdi Sakhabakhsh
Khanevadeh Hospital (AJA), Kaj Avenue, Shariati Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1613916411 +98 21 7750 7512 drsakha2013@gmail.com Artesh University of Medical Sciences Iran (Islamic Republic of) Patients with the age between 20- 50 years old Memory impairment after recovery from Covid-19 Volunteer to participate in the study 20 years 50 years Both History of previous cognitive problems History of CVA, head trauma or Cerebral hemorrhage History of underlying physical illnesses affecting cognitive function such as cancer, thyroid disorders, physical disorders with features of cognitive impairment such as Alzheimer's or any type of degenerative neurological disorder such as Parkinson's History of underlying mental illnesses such as major depression, anxiety disorders and psychotic disorders Use of drugs that affect cognitive function such as antidepressants, benzodiazepines, and anticonvulsants such as phenobarbital Drug, stimulant and alcohol using B97.21 SARS-associated coronavirus as the cause of diseases classified elsewhere Treatment - Drugs N/A Intervention group: This group is treated with Donepezil Hydrochloride with the brand name Aricept at a dose of 5 mg (half a tablet for the first 5 nights and then one tablet overnight for 3 months and from 3 months to 6 months after starting the drug are reached the dose10 mg daily). This drug is FDA-APPROVED for the treatment of Alzheimer's disease and is currently routinely prescribed in Iran. Control group: This group is not face to special intervention and is examined in parallel with the case group in terms of memory indexes. Score of Wechsler Memory Scale Test. Timepoint: Measurement of memory indices at the beginning of the study (before intervention), one month later, three months later and six months after the intervention. Method of measurement: The Wechsler Memory Scale. Artesh University of Medical Sciences Approved 2021-08-15 Research Ethics Committees of AJA University of Medical Sciences AJA University of Medical Sciences, Etemadzadeh Avenue, West Fatemi Street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)