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 of inflammatory cytokines 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 100 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 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 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
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Intervention groups
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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
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Main outcome variables
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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
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Reason for update
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Changing the dose of medication in the intervention and control groups.
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Acronym
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IRCT registration information
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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
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Registration date
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2018-03-19, 1396/12/28
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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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2018-04-20, 1397/01/31
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Expected recruitment end date
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2019-05-21, 1398/02/31
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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 inflammatory cytokines 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 inflammatory cytokines 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 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
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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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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
100
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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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2018-02-24, 1396/12/05
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Ethics committee reference number
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IR.UMSHA.REC.1396.820
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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I63
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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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Measuring serum level of TNF-α
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Timepoint
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Before intervention and 3 days later
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Method of measurement
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Through laboratory test
2
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Description
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Measuring serum level of IL-6
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Timepoint
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Before intervention and 3 days later
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Method of measurement
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Through laboratory test
3
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Description
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Measuring serum level of ICAM-1
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Timepoint
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Before intervention and 3 days later
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Method of measurement
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Through laboratory test
4
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Description
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Measuring serum level of NSE
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Timepoint
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Before intervention and 3 days later
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Method of measurement
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Through laboratory test
Intervention groups
1
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Description
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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
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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 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
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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