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Effects of oral administration of ubiquinone in cerebral stroke patients on the neurologic, psycho-cognitive and oxidative stress disorders

Protocol summary

Study aim
the effects of coenzyme Q10 on oxidative, psychological and sensory-motor indices in patients with acute ischemic stroke
Design
The study is a clinical trial that is double-blind. 50 patients are selected and divided into two groups of 25 patients; The control group receiving placebo; Patients are placed in both groups according to age, gender and severity of stroke so that the two groups are mostly the same. Patients and medical staff will be blinded and only the evaluating researcher is aware of the patient classification.
Settings and conduct
In this study, stroke patients who have been admitted to the neurology ward of Besat Hospital in Hamadan are invited to the study. They begin their healing process. In the intervention group, each patient received 600 mg of coenzyme Q10 daily in the form of 200 mg capsules for 30 days. In the control group, they begin their treatment with placebo capsules that are similar in appearance to the therapy group. Patients and treatment staff will not be aware of the type of capsules.
Participants/Inclusion and exclusion criteria
Patients admitted for acute ischemic stroke can participate in this study; Patients with other neurodegenerative disorders, acute mental disorders, liver or kidney malignancies, rheumatism, and chronic infections, as well as patients who have taken vitamin supplement in the past month; wont be accepted in this study.
Intervention groups
n this study, patients are divided into two groups; The first group of patients receive therapeutic intervention (coenzyme Q10 capsules) and the other group receives placebo capsules.
Main outcome variables
Oxidative indicators include total oxidative capacity, total thiol capacity, malondialdehyde and superoxide dismutase are biochemical variables; Sensory-motor and psychological functions, daily physical activities.

General information

Reason for update
Acronym
CoQ10
IRCT registration information
IRCT registration number: IRCT20210907052400N2
Registration date: 2021-10-06, 1400/07/14
Registration timing: prospective

Last update: 2021-10-06, 1400/07/14
Update count: 0
Registration date
2021-10-06, 1400/07/14
Registrant information
Name
Siamak Shahidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3822 2104
Email address
shahidi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-12, 1400/07/20
Expected recruitment end date
2022-07-21, 1401/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of oral administration of ubiquinone in cerebral stroke patients on the neurologic, psycho-cognitive and oxidative stress disorders
Public title
The effects of coenzyme Q10 on cerebral infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with acute ischemic stroke Patients who have had a stroke for the first time Patients between the ages of 20 and 80
Exclusion criteria:
Having other neurodegenerative disorders Having acute mental disorders Having liver and kidney malignancies Having rheumatism and chronic infections Taking vitamin supplements and immune boosters in the last month
Age
From 20 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
n this study, a neurologist selects ischemic stroke patients according to inclusion and non-inclusion criteria and introduces them to researchers. After fully explaining the treatment process of this study to patients and obtaining written consent, the researchers enter the patients into the study. After conducting initial assessments, the evaluating researcher provides the physician and nurses with therapeutic intervention, including capsules containing CO Q10 powder and placebo capsules (containing glucose powder), to be placed in the patient's order. The capsules are exactly the same in appearance and packaging, and the medical staff will not be aware of their main contents. The leader researcher in this study is blind and only researchers evaluating and analyzing the data will be aware of the patient classification.
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
Hamadan university of medical sciences, Shahid Fahmideh Blvd, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2021-09-04, 1400/06/13
Ethics committee reference number
IR.UMSHA.REC.1400.448

Health conditions studied

1

Description of health condition studied
Ischemic stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction

Primary outcomes

1

Description
Oxidative stress
Timepoint
Immediately after the stroke event and before starting coenzyme Q10 treatment and then 30 days after consuming oral coenzyme Q10
Method of measurement
Spectroscopy (by taking a blood sample)

2

Description
Sensory-motor function
Timepoint
Immediately after the stroke event and before starting coenzyme Q10 treatment and then 30 days after consuming oral coenzyme Q10
Method of measurement
Using Berg Balance Scale

3

Description
Psycho-cognitive function
Timepoint
Immediately after the stroke event and before starting coenzyme Q10 treatment and then 30 days after consuming oral coenzyme Q10
Method of measurement
Using the MoCA questionnaire

4

Description
Physical activity rate
Timepoint
Immediately after the stroke event and before starting coenzyme Q10 treatment and then 30 days after consuming oral coenzyme Q10
Method of measurement
Using SIMPAQ questionnaire and Barthel index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Half of the patients placed in the intervention group by the researcher; After initial evaluation of the initial variables and discharge from the hospital, they begin interventional therapy, which is complementary drug therapy with coenzyme Q10. In this study, patients will consume 600 mg of oral CoQ10 daily in the form of 200 mg capsules (3 servings per day) one hour before the main meals of breakfast, lunch and dinner for 30 days. The coenzyme Q10 oral powder used in this study; It is 98% pure and is made in South Korea.
Category
Treatment - Drugs

2

Description
Control group: The other half of the patients included in the study will be in the control group by the researcher of this study. All evaluations of patients in the intervention group will be performed at the beginning of the study and after discharge from the hospital, as in the first group, they will receive placebo capsules as complementary therapy; Take 3 servings of placebo capsules for 30 days. Patients who are blinded by the type of segmentation and the type of intervention; They receive a 200 mg capsule similar to the intervention capsules. The contents of the capsules of this group are filled with glucose powder.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Be'sat hospaital
Full name of responsible person
Ali Mojaver
Street address
Be'sat hospital, Shahid Beheshti Blvd, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6516798798
Phone
+98 81 3265 0030
Email
besat@umsha.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeed Bashirian
Street address
Hamadan university of medical sciences, Shahid Fahmideh Blvd, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Email
m_research@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
Hamedan University of Medical Sciences
Full name of responsible person
Mojtaba Khazaei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Be'sat hospital, Shahid Beheshti Blvd, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6516798798
Phone
+98 81 3565 0030
Email
khazaeimojtaba@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Siamak Shahidi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Department of physiology, School of medicine, Hamadan University of medical sciences, Shahid Fahmide St, Hamedan
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3822 2104
Email
shahidi@umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ali Mojaver
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
Department of Neurosciences, School of sciences and advanced technologies in medicine, Hamadan university of medical sciences. Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3823 1446
Email
a.mojaver@edu.umsha.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
In this study, only the results related to the study variables will be published
When the data will become available and for how long
Access starts 6 months after the results are published
To whom data/document is available
All people who are related to scientific and academic centers and industries related to health care can apply.
Under which criteria data/document could be used
Only as a scientific source with the names of the authors are allowed to use the results.
From where data/document is obtainable
Using e-mail addresses, they can contact the researchers of this study and the Vice Chancellor for Research and Technology of the University. Dr. Siamak Shahidi, shahidi@umsha.ac.ir Dr. Mojtaba, Khazaei, khazaeimojtaba@yahoo.com Ali Mojaver, a.mojaver.edu@umsha.ac.ir
What processes are involved for a request to access data/document
Applicants can send an email to the author responsible for the published articles. Request a copy of the article file. To be sent to them by e-mail.
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