Effect of high-dose oral Acetyl-L-carnitine versus placebo on serum level of oxidative and nirtosative stress and clinical outcomes in patients with ischemic stroke: a double-blind randomized clinical trialApproved
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General information
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changing the time point of National Institutes of Health Stroke Scale and Modified Rankin Scale for Neurologic Disability outcomes
changing the time point of National Institutes of Health Stroke Scale and Modified Rankin Scale for Neurologic Disability outcomes
empty
تغییر مقاطع زمانی اندازه گیری پیامدهای مقیاس مؤسسه های ملی بهداشت و درمان سکته مغزی و مقیاس اصلاح شده برای ناتوانی نورولوژیک
تغییر مقاطع زمانی اندازه گیری پیامدهای مقیاس مؤسسه های ملی بهداشت و درمان سکته مغزی و مقیاس اصلاح شده برای ناتوانی نورولوژیک
Primary outcomes
#1
Before intervention and 3 days after intervention
Before intervention and 90 days after intervention
Before intervention and 390 days after intervention
قبل از مداخله و 3 روز بعد
قبل از مداخله و 90 روز بعد
قبل از مداخله و 390 روز بعد
#2
Before intervention and 3 days after intervention
Before intervention and 90 days after intervention
Before intervention and 390 days after intervention
قبل از مداخله و 3 روز بعد
قبل از مداخله و 90 روز بعد
قبل از مداخله و 390 روز بعد
Protocol summary
Study aim
To assess the effect of high-dose oral Acetyl- L-Carnitine versus placebo on serum level ofoxidative and nirtosative stress and clinical outcomes in patients with ischemic stroke
Design
This a double-blind randomized clinical trial, phase II, in which 90 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
This study was conducted as a clinical, randomized, and double blind clinical trial on patients with ischemic stroke referred to Farshchian Sina Hospital in Hamedan. The researcher and participants were blinded.
Participants/Inclusion and exclusion criteria
Criteria for entering the study: aged 18 to 85 years; focal neurological disorder;Ischemic stroke; Non-pregnancy and lactation; Hospitalization within the first 24 hours after stroke; ischemic stroke for the first time. Exit criteria: Evidence on acute or chronic intracerebral hemorrhage and brain aneurysm;The existence of any other etiology other than ischemia.
Intervention groups
Intervention group: Routine stroke treatment plus oral Acetyl-L-carnitine capsule, 500 mg, every 8 hours, for 3 days. Control group: Routine stroke treatment plus oral placebo, every 8 hours, for 3 days.
Main outcome variables
Serum level of lipid peroxidation, nitric oxide, total antioxidant capacity, thiol, activity of glutathione peroxidase, catalase, superoxide dismutase, NIHSS, mRS
General information
Reason for update
changing the time point of National Institutes of Health Stroke Scale and Modified Rankin Scale for Neurologic Disability outcomes
Acronym
IRCT registration information
IRCT registration number:IRCT20150629022965N17
Registration date:2018-07-25, 1397/05/03
Registration timing:registered_while_recruiting
Last update:2020-02-17, 1398/11/28
Update count:1
Registration date
2018-07-25, 1397/05/03
Registrant information
Name
Maryam Mehrpooya
Name of organization / entity
School of Pharmacy,Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3821 8684
Email address
m.mehrpoya@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-21, 1397/04/30
Expected recruitment end date
2019-04-19, 1398/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of high-dose oral Acetyl-L-carnitine versus placebo on serum level of oxidative and nirtosative stress and clinical outcomes in patients with ischemic stroke: a double-blind randomized clinical trialApproved
Public title
Effect of high-dose oral Acetyl-L-carnitine versus placebo on serum level of oxidative and nirtosative stress and clinical outcomes in patients with ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 85 years old
Ischemic stroke Stroke for the first time
Local neurologic disorder
Patients who have been admitted for the first 24 hours after the stroke
Exclusion criteria:
Pregnancy or breastfeeding
Inflammatory disease
Asthma
History of anaphylaxis shock
Age
From 18 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double-blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Pharmacy school, Hamadan University of Medical Sciences, in front of Mardom park, Shahid Fahmideh Blvd, Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838678
Approval date
2018-06-08, 1397/03/18
Ethics committee reference number
IR.UMSHA.1397.163
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
Serum level of lipid peroxidation
Timepoint
Before intervention and 3 days after intervention
Method of measurement
kit
2
Description
Serum levels of nitric oxide
Timepoint
Before intervention and 3 days after
Method of measurement
kit
3
Description
Serum levels of total antioxidant capacity
Timepoint
Before intervention and 3 days after
Method of measurement
kit
4
Description
Catalase activity
Timepoint
Before intervention and 3 days after intervention
Method of measurement
kit
5
Description
Activity of superoxide dismutase
Timepoint
Before intervention and 3 days after intervention
Method of measurement
kit
6
Description
Serum level of thiol
Timepoint
Before intervention and 3 days after intervention
Method of measurement
kit
7
Description
Activity of Glutathione Peroxidase
Timepoint
Before intervention and 3 days after intervention
Method of measurement
kit
8
Description
National Institutes of Health Stroke Scale
Timepoint
Before intervention and 90 days after intervention
Method of measurement
Questionnaire
9
Description
Modified Rankin Scale for Neurologic Disability
Timepoint
Before intervention and 90 days after intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, patients will receive oral Acetyl-l-Carnitine, one 500mg capsule, at the dose of 1 g three times a day (every 8 hours) for 3 days in addition to the standard treatment.
Category
Treatment - Drugs
2
Description
Control group: In the control group, patients will receive placebo at the dose of 1 g, three times a day (every 8 hours) for 3 days in addition to the standard treatment.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan Farshchian Sina Hospital
Full name of responsible person
Maryam Mehrpooya
Street address
Farshchian Sina Hospital, Mirzadeh Eshghi St., Hamedan
City
Hamedan
Province
Hamadan
Postal code
6516848741
Phone
+98 81 8383 0717
Email
m_mehrpooya2003@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Pharmacy school, Hamedan University of Medical Sciences, in front of Mardom park, Shahid Fahmideh Blvd., Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 1010
Email
S_Bashirian@yahoo.com
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
Maryam Mehrpooya
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy school,Hamadan University of Medical Sciences,in front of Mardom park,Shahid Fahmideh Blvd,Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Email
m_mehrpooya2003@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Mehrpooya
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy school, Hamedan University of Medical Sciences, in front of Mardom park, Shahid Fahmideh Blvd. Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Email
m_mehrpooya2003@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Parnaz Abolfathi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy school, Hamadan University of Medical Sciences, in front of Mardom park, Shahid Fahmideh Blvd. Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3831 6546
Email
parnaz.ablf@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