The effect on cognitive disorders in patients with moderate stroke
Design
This study is a clinical trial with three case-control and control groups that 165 patients with moderate brain injury from Isfahan hospitals will be included in the study.
Settings and conduct
No blinding was performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient consent to enter the study
Patients with moderate concussion with an GCS of 12-8.
Exclusion criteria: Consciousness coefficient greater than 12
History of any brain disorders in the patient
Patients with Acetylcholinesterase contraindications
Intervention groups
In the first group: Rivastigmine is prescribed for one month at a dose of 1.5 mg and then the dose of the drug will be increased by 3.5 mg. This drug is prescribed for patients in this group for up to three months.
In the second group: Donepezil is prescribed for 1 month at a dose of 5 mg, after which the dose will be increased by 10 mg. This drug is prescribed for patients in this group for up to three months.
Main outcome variables
Impact on the patient's cognitive disorders
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210819052232N1
Registration date:2021-11-07, 1400/08/16
Registration timing:prospective
Last update:2021-11-07, 1400/08/16
Update count:0
Registration date
2021-11-07, 1400/08/16
Registrant information
Name
Iman Salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3685 7150
Email address
iman_salehi19@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Rivastigmine and Donepezil on cognitive disorders in patients with moderate stroke
Public title
Effectiveness of Rivastigmine and Donepezil on cognitive disorders
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patient consent to enter the study
Patients with moderate concussion with an GCS of 12-8.
Exclusion criteria:
Consciousness coefficient greater than 12
History of any brain disorders in the patient
Patients with Acetylcholinesterase contraindications
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
165
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib St., Shiraz Gate
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-08-01, 1400/05/10
Ethics committee reference number
IR.MUI.MED.REC.1400.350
Health conditions studied
1
Description of health condition studied
Cognitive disorder
ICD-10 code
G31.84
ICD-10 code description
Mild cognitive impairment, so stated
Primary outcomes
1
Description
Reduce cognitive impairment
Timepoint
After discharge and three months after
Method of measurement
MMSE, NUCog, Moca questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
3
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Mehdi Shafiei
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.,
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Mehdishafiei82@gmail.com
2
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Mehdi Shafiei
Street address
Kashani ST
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3233 0091
Email
kashani@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjuye Javanmardi
Street address
Isfahan University of Medical Sciences, hezar jarib S.T
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Shafiei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.,
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Mehdishafiei82@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Shafiei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Al-Zahra hospital, Sofeh St.,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Mehdishafiei82@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Iman Salehi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Al-Zahra hospital, Sofeh St.,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
iman_salehi19@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available