Protocol summary
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Study aim
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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
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Design
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This a double-blind randomized clinical trial, phase II, in which 88 eligible patients will be randomly assigned to the intervention and control groups
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Settings and conduct
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The eligible patients with ischemic stroke who will refer to Sina hospital (Tehran, Iran) during the study period will be enrolled in the trial
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Serum level of lipid peroxidation, nitric oxide, total antioxidant capacity, thiol, activity of glutathione peroxidase, catalase, superoxide dismutase, NIHSS, mRS
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150629022965N16
Registration date:
2018-07-15, 1397/04/24
Registration timing:
prospective
Last update:
2020-02-06, 1398/11/17
Update count:
2
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Registration date
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2018-07-15, 1397/04/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-07-22, 1397/04/31
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Expected recruitment end date
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2019-04-20, 1398/01/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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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
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 85 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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Sample size
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Target sample size:
88
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The patients will be randomly assigned to intervention and control groups using block randomization
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-06-08, 1397/03/18
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Ethics committee reference number
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IR.UMSHA.REC.1397.136
Health conditions studied
1
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Description of health condition studied
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ischemic stroke
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ICD-10 code
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163
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ICD-10 code description
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Cerebral infarction
Primary outcomes
1
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Description
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Serum level of lipid peroxidation
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Timepoint
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Before intervention and 3 days after intervention
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Method of measurement
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kit
2
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Description
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Serum levels of nitric oxide
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Timepoint
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Before intervention and 3 days after intervention
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Method of measurement
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kit
3
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Description
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Serum levels of total antioxidant capacity
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Timepoint
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Before intervention and 3 days after intervention
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Method of measurement
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kit
4
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Description
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Catalase activity
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Timepoint
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Before intervention and 3 days after intervention
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Method of measurement
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kit
5
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Description
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Activity of superoxide dismutase
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Timepoint
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Before intervention and 3 days after intervention
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Method of measurement
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kit
6
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Description
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Serum level of thiol
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Timepoint
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Before intervention and 3 days after intervention
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Method of measurement
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kit
7
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Description
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Activity of Glutathione Peroxidase
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Timepoint
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Before intervention and 3 days after intervention
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Method of measurement
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kit
8
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Description
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National Institutes of Health Stroke Scale
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Timepoint
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Before intervention and 90 days after intervention
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Method of measurement
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Questionnaire
9
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Description
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Modified Rankin Scale for Neurologic Disability
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Timepoint
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Before intervention and 90 days after intervention
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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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
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Category
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Treatment - Drugs
2
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Description
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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
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available