Effect of high-dose oral N-acetylcysteine versus placebo on serum level of inflammatory cytokines in patients with ischemic stroke: a double-blind randomized clinical trial
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Protocol summary
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
Intervention group: Routine stroke treatment plus oral N-acetylcysteine tablet (manufactured by Hexal Pharmaceutical Co.) with a loading dose of 4 g and then 2 g every 12 hours for 2 days
Control group: Routine stroke treatment plus placebo tablet (manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) with a loading dose of two tablets and then one placebo tablet every 12 hours for 2 days
Intervention group: Routine stroke treatment plus oral N-acetylcysteine tablet 200(manufactured by Hexal Pharmaceutical Co.) with a loading dose of 4 g and then 2 g every 12 hours for 2 days Control group: Routine stroke treatment plus oralplacebo tablet (manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) with a loading dose of two tablets and then one placebo tablet every 12 hours 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 کنترل: درمان روتین سکته مغزی بعلاوه دارونما خوراکی هر 12 ساعت به مدت 2 روز
گروه مداخله: درمان روتین سکته مغزی بعلاوه قرص ان –استیل سیستئین خوراکی (ساخت شرکت داروسازی هگزال) با دوز بارگذاری 4 گرم سپس 2 گرم هر 12 ساعت به مدت 2 روز
گروه کنترل: درمان روتین سکته مغزی بعلاوه قرص دارونما (ساخت لابراتوار داروسازی دانشکده داروسازی دانشگاه علوم پزشکی همدان) با دو قرص بارگذاری دارونما سپس قرص دارونما هر 12 ساعت به مدت 2 روز
گروه مداخله: درمان روتین سکته مغزی بعلاوه قرص 200 میلی گرمی ان- –استیل سیستئین خوراکی (ساخت شرکت داروسازی هگزال) با دوز بارگذاری 4 گرم سپس 2 گرم هر 12 ساعت به مدت 2 روز گروه کنترل: درمان روتین سکته مغزی بعلاوه قرص دارونما خوراکی(ساخت لابراتوار داروسازی دانشکده داروسازی دانشگاه علوم پزشکی همدان) با دو قرص بارگذاری دارونما سپس قرص دارونما هر 12 ساعت به مدت 2 روز
General information
empty
Changing the dose of medication in the intervention and control groups.
Changing the dose of medication in the intervention and control groups.
empty
تغییر دوز دارو در گروه های مداخله و کنترل
تغییر دوز دارو در گروه های مداخله و کنترل
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 (manufactured by Hexal Pharmaceutical Co.) with a loading dose of 4 g and then 2 g every 12 hours for 2 days
Intervention group: Routine stroke treatment plus oral N-acetylcysteine tablet 200(manufactured by Hexal Pharmaceutical Co.) with a loading dose of 4 g and then 2 g every 12 hours 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 ان –استیل سیستئین خوراکی (ساخت شرکت داروسازی هگزال) با دوز بارگذاری 4 گرم سپس 2 گرم هر 12 ساعت به مدت 2 روز
گروه مداخله: درمان روتین سکته مغزی بعلاوه قرص 200 میلی گرمی ان- –استیل سیستئین خوراکی (ساخت شرکت داروسازی هگزال) با دوز بارگذاری 4 گرم سپس 2 گرم هر 12 ساعت 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 placebo tablet (manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) with a loading dose of two tablets and then one placebo tablet every 12 hours for 2 days
Control group: Routine stroke treatment plus oralplacebo tablet (manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) with a loading dose of two tablets and then one placebo tablet every 12 hours 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 قرص دارونما (ساخت لابراتوار داروسازی دانشکده داروسازی دانشگاه علوم پزشکی همدان) با دو قرص بارگذاری دارونما سپس قرص دارونما هر 12 ساعت به مدت 2 روز
گروه کنترل: درمان روتین سکته مغزی بعلاوه قرص دارونما خوراکی(ساخت لابراتوار داروسازی دانشکده داروسازی دانشگاه علوم پزشکی همدان) با دو قرص بارگذاری دارونما سپس قرص دارونما هر 12 ساعت به مدت 2 روز
Protocol summary
Study aim
To assess the effect of high-dose oral N-acetylcysteine versus placebo on serum level of inflammatory cytokines in patients with ischemic stroke
Design
This a double-blind randomized clinical trial, phase II, in which 100 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 during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 85 years
Ischemic stroke
Stroke for the first time
Local neurologic disorder
Hospitalization within the first 24 hours after stroke
Exclusion criteria:
Pregnancy or breastfeeding
Inflammatory disease
Asthma
A history of anaphylaxis shock
Intervention groups
Intervention group: Routine stroke treatment plus oral N-acetylcysteine tablet (manufactured by Hexal Pharmaceutical Co.) with a loading dose of 4 g and then 2 g every 12 hours for 2 days
Control group: Routine stroke treatment plus placebo tablet (manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) with a loading dose of two tablets and then one placebo tablet every 12 hours for 2 days
Main outcome variables
Primary outcome:
Measuring serum level of TNF-α before intervention and 3 days later through laboratory test
Measuring serum level of IL-6 before intervention and 3 days later through laboratory test
Measuring serum level of ICAM-1 before intervention and 3 days later through laboratory test
Measuring serum level of NSE before intervention and 3 days later through laboratory test
General information
Reason for update
Changing the dose of medication in the intervention and control groups.
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N215
Registration date:2018-03-19, 1396/12/28
Registration timing:prospective
Last update:2020-01-23, 1398/11/03
Update count:1
Registration date
2018-03-19, 1396/12/28
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-20, 1397/01/31
Expected recruitment end date
2019-05-21, 1398/02/31
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 inflammatory cytokines 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 inflammatory cytokines in patients with ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 85 years
Ischemic stroke
Stroke for the first time
Local neurologic disorder
Hospitalization within the first 24 hours after stroke
Exclusion criteria:
Pregnancy or breastfeeding
Inflammatory disease
Asthma
A history of anaphylaxis shock
Age
From 18 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
100
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-02-24, 1396/12/05
Ethics committee reference number
IR.UMSHA.REC.1396.820
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
Measuring serum level of TNF-α
Timepoint
Before intervention and 3 days later
Method of measurement
Through laboratory test
2
Description
Measuring serum level of IL-6
Timepoint
Before intervention and 3 days later
Method of measurement
Through laboratory test
3
Description
Measuring serum level of ICAM-1
Timepoint
Before intervention and 3 days later
Method of measurement
Through laboratory test
4
Description
Measuring serum level of NSE
Timepoint
Before intervention and 3 days later
Method of measurement
Through laboratory test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine stroke treatment plus oral N-acetylcysteine tablet (manufactured by Hexal Pharmaceutical Co.) with a loading dose of 4 g and then 2 g every 12 hours for 2 days
Category
Treatment - Drugs
2
Description
Control group: Routine stroke treatment plus placebo tablet (manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) with a loading dose of two tablets and then one placebo tablet every 12 hours for 2 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Maryam Sabet Ghadam
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
maryana.sbt@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.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
Dr. Maryam Mehrpoya
Position
Pharmacologist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
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
Dr. Mehrdokht Mazdeh
Position
Neurologist
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
mehrdokhtmazdeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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