Effect of high-dose oral N-acetylcysteine versus placebo on serum level of oxidative and nirtosative stress and clinical outcomes in patients with ischemic stroke: a double-blind randomized clinical trial
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Intervention groups
#1
Intervention group: routine stroke treatment plus oral N-acetylcysteine tablet 200 g every 12 hours for 2 days
Intervention group: routine stroke treatment plus oral N-acetylcysteine tablet 200 mg with 4 g loading dose,after 18-24 h 4g,every 12 hours 2g for 2 days
Intervention group: routine stroke treatment plus oral N-acetylcysteine tablet 200 mg with 4 g everyloading dose,after 18-24 h 4g,every 12 hours 2g for 2 days
گروه مداخله:درمان روتین سکته مغزی بعلاوه قرص 200 میلی گرمی ان-استیل سیستئین خوراکی 2 گرم هر 12 ساعت به مدت 2 روز
گروه مداخله:درمان روتین سکته مغزی بعلاوه قرص 200 میلی گرمی ان –استیل سیستئین خوراکی با دوزبارگذاری 4 گرم،پس از گذشت 24-18 ساعت 4گرم ،هر 12 ساعت 2 گرم به مدت 2 روز
گروه مداخله:درمان روتین سکته مغزی بعلاوه قرص 200 میلی گرمی ان- –استیل سیستئین خوراکی 2با دوزبارگذاری 4 گرم،پس از گذشت 24-18 ساعت 4گرم ،هر 12 ساعت 2 گرم به مدت 2 روز
#2
Control group: routine stroke treatment plus oral placebo every 12 hours for 2 days
Control group: routine stroke treatment plus oral placebo with 4 g loading dose,after 18-24 h 4g,every 12 hours 2g for 2 days
Control group: routine stroke treatment plus oral placebo everywith 4 g loading dose,after 18-24 h 4g,every 12 hours 2g for 2 days
گروه کنترل: درمان روتین سکته مغزی بعلاوه دارونما خوراکی هر 12 ساعت به مدت 2 روز
گروه کنترل: درمان روتین سکته مغزی بعلاوه دارونما خوراکی با دوزبارگذاری 4 گرم،پس از گذشت 24-18 ساعت 4گرم ،هر 12 ساعت 2 گرم به مدت 2 روز هر 12 ساعت به مدت 2 روز
گروه کنترل: درمان روتین سکته مغزی بعلاوه دارونما خوراکی با دوزبارگذاری 4 گرم،پس از گذشت 24-18 ساعت 4گرم ،هر 12 ساعت 2 گرم به مدت 2 روز هر 12 ساعت به مدت 2 روز
Recruitment centers
#1
Name of recruitment center - English: Hamedan Farshchian Sina Hospital
Name of recruitment center - Persian: بیمارستان فرشچیان سینا همدان
Full name of responsible person - English: Maryam Mehrpooya
Full name of responsible person - Persian: مریم مهرپویا
Street address - English: Farshchian Sina Hospital, Mirzadeh Eshghi St, Hamedan
Street address - Persian: همدان ، خیابان میرزاده عشقی ، مرکز آموزشی درمانی فرشچیان سینا
City - English: Hamedan
City - Persian: همدان
Province: Hamadan
Country: Iran (Islamic Republic of)
Postal code: 6516848741
Phone: +98 81 3838 0717
Fax:
Email: m_mehrpooya2003@yahoo.com
Web page address:
Name of recruitment center - English: Hamedan Farshchian Sina Hospital
Name of recruitment center - Persian: بیمارستان فرشچیان سینا همدان
Full name of responsible person - English: Maryam Mehrpooya
Full name of responsible person - Persian: مریم مهرپویا
Street address - English: Farshchian Sina Hospital, Mirzadeh Eshghi St., Hamedan
Street address - Persian: همدان ، خیابان میرزاده عشقی ، مرکز آموزشی درمانی فرشچیان سینا
City - English: Hamedan
City - Persian: همدان
Province: Hamadan
Country: Iran (Islamic Republic of)
Postal code: 6516848741
Phone: +98 81 3838 0717
Fax:
Email: m_mehrpooya2003@yahoo.com
Web page address:
Name of recruitment center - English: Hamedan Farshchian Sina Hospital Name of recruitment center - Persian: بیمارستان فرشچیان سینا همدان Full name of responsible person - English: Maryam Mehrpooya Full name of responsible person - Persian: مریم مهرپویا Street address - English: Farshchian Sina Hospital, Mirzadeh Eshghi St., Hamedan Street address - Persian: همدان ، خیابان میرزاده عشقی ، مرکز آموزشی درمانی فرشچیان سینا City - English: Hamedan City - Persian: همدان Province: Hamadan Country: Iran (Islamic Republic of) Postal code: 6516848741 Phone: +98 81 3838 0717 Fax: Email: m_mehrpooya2003@yahoo.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Saeed Bashirian
Full name of responsible person - Persian: سعید بشیریان
Street address - English: Pharmacy school, Hamedan University of Medical Sciences, in front of Mardom park, Shahid Fahmideh Blvd. Hamedan
Street address - Persian: همدان ، بلوار شهيد فهميده ، روبروي بوستان مردم ، دانشگاه علوم پزشكي و خدمات بهداشتي همدان ، دانشكده داروسازي
City - English: Hamedan
City - Persian: همدان
Province: Hamadan
Country: Iran (Islamic Republic of)
Postal code: 6517838678
Phone: +98 81 3838 1010
Fax:
Email: S_Bashirian@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Saeed Bashirian
Full name of responsible person - Persian: سعید بشیریان
Street address - English: Pharmacy school, Hamedan University of Medical Sciences, in front of Mardom park, Shahid Fahmideh Blvd., Hamedan
Street address - Persian: همدان ، بلوار شهيد فهميده ، روبروي بوستان مردم ، دانشگاه علوم پزشكي و خدمات بهداشتي همدان ، دانشكده داروسازي
City - English: Hamedan
City - Persian: همدان
Province: Hamadan
Country: Iran (Islamic Republic of)
Postal code: 6517838678
Phone: +98 81 3838 1010
Fax:
Email: S_Bashirian@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Saeed Bashirian Full name of responsible person - Persian: سعید بشیریان Street address - English: Pharmacy school, Hamedan University of Medical Sciences, in front of Mardom park, Shahid Fahmideh Blvd., Hamedan Street address - Persian: همدان ، بلوار شهيد فهميده ، روبروي بوستان مردم ، دانشگاه علوم پزشكي و خدمات بهداشتي همدان ، دانشكده داروسازي City - English: Hamedan City - Persian: همدان Province: Hamadan Country: Iran (Islamic Republic of) Postal code: 6517838678 Phone: +98 81 3838 1010 Fax: Email: S_Bashirian@yahoo.com Web page address:
Protocol summary
Study aim
To assess the effect of high-dose oral N-acetylcysteine 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 88 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with ischemic stroke who will refer to Sina hospital (Tehran, Iran) during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria: age: 18 to 85 years old; Ischemic stroke for the first time; local neurologic disorder hospitalization within the first 24 hours after stroke. Exclusion criteria: pregnancy or breast feeding; inflammatory disease; Asthma; history of anaphylactic shock.
Intervention groups
Intervention group: routine stroke treatment plus oral N-acetylcysteine tablet 200 g every 12 hours for 2 days. Control group: routine stroke treatment plus oral placebo every 12 hours for 2 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
Acronym
IRCT registration information
IRCT registration number:IRCT20150629022965N16
Registration date:2018-07-15, 1397/04/24
Registration timing:prospective
Last update:2020-01-25, 1398/11/05
Update count:2
Registration date
2018-07-15, 1397/04/24
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
2018-07-22, 1397/04/31
Expected recruitment end date
2019-04-20, 1398/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of high-dose oral N-acetylcysteine versus placebo on serum level of oxidative and nirtosative stress and clinical outcomes in patients with ischemic stroke: a double-blind randomized clinical trial
Public title
Effect of high-dose oral N-acetylcysteine 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:
Age: 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:
88
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.REC.1397.136
Health conditions studied
1
Description of health condition studied
ischemic stroke
ICD-10 code
163
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 intervention
Method of measurement
kit
3
Description
Serum levels of total antioxidant capacity
Timepoint
Before intervention and 3 days after intervention
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 3 days after intervention
Method of measurement
Questionnaire
9
Description
Modified Rankin Scale for Neurologic Disability
Timepoint
Before intervention and 3 days after intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: routine stroke treatment plus oral N-acetylcysteine tablet 200 mg with 4 g loading dose,after 18-24 h 4g,every 12 hours 2g for 2 days
Category
Treatment - Drugs
2
Description
Control group: routine stroke treatment plus oral placebo with 4 g loading dose,after 18-24 h 4g,every 12 hours 2g for 2 days
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 3838 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, 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 updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Sabetghadam
Position
student
Latest degree
Medical doctor
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
maryana.sbt@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