To assess and evaluate the efficacy of the generic medication “Memoral” on the recovery of the memory dysfunction in patients with TBI
Design
Two arm parallel group single-blind, Placebo-controlled phase 4randomized trial.
Settings and conduct
This study is performed at Shiraz University of Medical Sciences, Trauma Research Center, on patients who have memory problems after mild brain injury.
Community Verified icon
Participants/Inclusion and exclusion criteria
In this study patients with the diagnosis of MTBI, who have the following criteria will be included in the study:
۱- Age between ۲۰ and ۶۰
۲- ۶th class education;
۳- Having no previous history of trauma
۴- Having no major psychiatric and neurologic disorders according to the self-report
۵- Having no judiciary issues or any probability of economic or insurance-related sue
۶- Having no hematologic disorder
Intervention groups
intervention group: receiving memoral capsule every eight hours (8 am - 4 pm - 12 pm) for a month
control group: receiving placebo every eight hours (8 am - 4 pm - 12 pm)
for a month
Main outcome variables
Patient memory function based on AVLT test results
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130310012776N8
Registration date:2022-02-11, 1400/11/22
Registration timing:registered_while_recruiting
Last update:2022-02-11, 1400/11/22
Update count:0
Registration date
2022-02-11, 1400/11/22
Registrant information
Name
Hosseinali Khalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3625 4206
Email address
khalili_h@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-04, 1400/11/15
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Memoral on the memory dysfunction after mild traumatic brain injury , a randomize clinical trial
Public title
effect of Memoral on memory after TBI
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 20 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand Boulevard, the central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2022-01-10, 1400/10/20
Ethics committee reference number
IR.SUMS.REC.1400.726
Health conditions studied
1
Description of health condition studied
Memory impairment after mild brain injury
ICD-10 code
S07.1
ICD-10 code description
Crushing injury of skull
Primary outcomes
1
Description
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)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: memoral capsules are given to patients every 8 hours at 8 am, 2 pm and 12 pm for one month.
Category
Treatment - Drugs
2
Description
Control group: placebo are given to patients every 8 hours at 8 am, 2 pm and 12 pm for one month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emtiaz trauma center
Full name of responsible person
Omid Yousefi
Street address
Chamran blvd, Emtiaz trauma center Zip code: 7194815711
City
Shiraz
Province
Fars
Postal code
۷۱۹۴۸۱۵۷۱۱
Phone
+98 71 3625 4206
Fax
Email
Trauma_research_center@yahoo.com
Web page address
https://traumarc.sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Street address
7th floor, Central building of Shiraz University of medical sciences
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
80
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
Shiraz University of Medical Sciences
Full name of responsible person
Hosseinali Khalili
Position
Associat professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Rajaee Hospital, Chamran Boulevard, Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
۷۱۹۴۸۱۵۷۱۱
Phone
+98 71 3625 4206
Fax
+98 71 3625 4206
Email
khalili_h@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hosseinali Khalili
Position
Associat professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Rajaee Hospital, Chamran Boulevard, Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3625 4206
Fax
+98 71 3625 4206
Email
khalili_h@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hosseinali Khalili
Position
Associat professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Rajaee Hospital, Chamran Boulevard, Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
۷۱۹۴۸۱۵۷۱۱
Phone
+98 71 3625 4206
Fax
+98 71 3625 4206
Email
khalili_h@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
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 become available and for how long
The data will be availableafter the results are published
To whom data/document is available
Members of Trauma Research Center, Shiraz University of Medical Sciences
Under which criteria data/document could be used
For possible use in future research, it will be made available to researchers with an approved researches
From where data/document is obtainable
Emtiaz Hospital Trauma Research Center
What processes are involved for a request to access data/document
The researcher's request will be reviewed after sending an official letter to the Trauma Center Research Council