Evaluation of the effect of Coenzyme Q10 on visual field,cognition abilities and serum levels of Beta secretase and oxidative factors in acute ischemic stroke patients with visual field defects
The aim of this study was to investigate the role of coenzyme Q10 in the treatment of visual disorders, especially visual field defects and cognitive impairments due to stroke and its effect on serum beta-secretase levels and oxidative balance .
Design
At the beginning of the study, visual field, visual acuity and Contrast sensitivity,cognition status as well as serum beta-secretase levels and oxidant and antioxidant status of patients are evaluated. Treatment for one month in two groups:1) oral coenzyme Q10,10mg/kg and 2)Placebo will be done. At the end, the mentioned factors will be measured again and possible changes will be analyzed based on statistical calculations.
Settings and conduct
The visual field will be performed by the "Rare Bit" perimetry. Visual acuity and contrast sensitivity assessments will be used by Snelln chart and Freiburg contrast test, respectively. Cognitive status will be assessed using standard questionnaires. serum Beta-secretase levels and oxidation status will be determined by the relevant kits according to approved protocols.The study will be performed at Shahid Beheshti Hospital of Qom University of Medical Sciences
Participants/Inclusion and exclusion criteria
Age between 18 and 80 years
maximum of one week has passed since the onset of stroke
Has visual field defect
Adequate level of awareness and cognition for performing tests and questionnaires.
exclud:
previous history of stroke
pre-stroke neurological disease such as Alzheimer's, Parkinson's, cognitive impairment and MS.
irreversible eye disease that can cause visual field defects such as glaucoma, cataracts, etc.
Consumption of other antioxidant drugs such as vitamins E, C and A, etc.
Taking immunosuppressive drugs for the past two months
Patients with uncontrolled diabetes and Hypertension
Intervention groups
1)Coenzyme Q10 ,n=32
2)Placebo ,n=32
Main outcome variables
visual field
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160524028046N2
Registration date:2022-03-18, 1400/12/27
Registration timing:prospective
Last update:2022-03-18, 1400/12/27
Update count:2
Registration date
2022-03-18, 1400/12/27
Registrant information
Name
Mohammad Hossein Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3252 0182
Email address
mhsharif2013@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2023-03-06, 1401/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Coenzyme Q10 on visual field,cognition abilities and serum levels of Beta secretase and oxidative factors in acute ischemic stroke patients with visual field defects
Public title
Evaluation of the effect of Coenzyme Q10 on visual field,cognition abilities and serum levels of Beta secretase and oxidative factors in acute ischemic stroke patients with visual field defects
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Acute ischemic stroke patients with visual field defects
Exclusion criteria:
Other neurological diseases such as Alzheimer's and MS
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
According to the method of random allocation rule, 32 balls called treatment group and 32 balls called placebo are mixed with each other and randomly removed one by one. The removed ball will not be replaced.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be duble blinded. Patients will be blinded to the type of intervention and the researcher who must evaluate and record the data will be blinded to the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Pajoohesh
City
Hamedan
Province
Hamadan
Postal code
6517838736
Approval date
2022-03-06, 1400/12/15
Ethics committee reference number
IR.UMSHA.REC.1400.969
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
8B11
ICD-10 code description
Cerebral ischaemic stroke
Primary outcomes
1
Description
Visual field
Timepoint
Monthly
Method of measurement
perimetry
Secondary outcomes
1
Description
serum beta secretase
Timepoint
Monthly
Method of measurement
Assay kit
2
Description
Quality of life based on vision
Timepoint
Monthly
Method of measurement
questionnaire
3
Description
Contrast sensitivity
Timepoint
monthly
Method of measurement
Freiburg CS Test
4
Description
oxidant Status
Timepoint
Monthly
Method of measurement
Assay kit
5
Description
Antioxidant Status
Timepoint
Monthly
Method of measurement
Assay kit
6
Description
Visual Acuity
Timepoint
Weekly
Method of measurement
Snellen chart
Intervention groups
1
Description
Intervention group:Patients will be treated with Coenzyme Q10 soft gel prepared from jalinus Pharmaceutical Company (Tehran-Iran),orally (10 mg/kg), daily for 30 days
Category
Treatment - Drugs
2
Description
Control group: Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Ehsan Sharifipour
Street address
Shahid Beheshti
City
Qom
Province
Ghoum
Postal code
3716993456
Phone
+98 25 3285 2720
Email
sharifipour.e@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abdolrahman Sarihi
Street address
Pajoohesh
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
sarihi@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
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
Ghoum University of Medical Sciences
Full name of responsible person
Ehsan Sharifipour
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Safa Shahr
City
Qom
Province
Ghoum
Postal code
3716993456
Phone
+98 25 3285 2720
Email
sharifipour.e@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
َAbdolrahman Sarihi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Pajoohesh
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
sarihi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohamad Hossein Sharif
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
Pajoohesh
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
mhsharif2013@gmail.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