Protocol summary
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Study aim
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The aim of this clinical trial is to assess efficacy of Nigella Sativa oil on ischemic stroke patient's functional outcome (at least 50% improvement in the 3-month NIHSS compared to the baseline score ) compared with placebo.
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Design
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A randomized controlled clinical trial and triple blind, parallel study
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Settings and conduct
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This study is conducted at Shahid Beheshti Hospital in Qom and is blinded by placebo
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: 1- Acute ischemic stroke hospitalization in Shahid beheshti hospital; 2-Not having a severe disability after stroke(NIHSS<20); . Exclusion criteria: 1- Request of patients to Exit from the study; 2- Previous chronic disease interferes with the performance evaluation in patients such as: chronic infections, liver or kidney failure, cancers; 3- Residual weakness of previous stroke; 4- Pregnancy or breastfeeding or any conditions that makes follow up impossible; 5- Sever loss of Consciousness; 6- Thrombolytic therapy; 7-Endarterectomy
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Intervention groups
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patient with patient with acute ischemic stroke which is divided into two groups of Nigella Sativa oil capsule and placebo capsule .placebo similar to the drug.
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Main outcome variables
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Disability of patients
General information
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Reason for update
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Acronym
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AEH
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IRCT registration information
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IRCT registration number:
IRCT20170112031893N4
Registration date:
2019-01-05, 1397/10/15
Registration timing:
prospective
Last update:
2019-01-14, 1397/10/24
Update count:
1
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Registration date
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2019-01-05, 1397/10/15
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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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2019-02-20, 1397/12/01
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Expected recruitment end date
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2019-08-23, 1398/06/01
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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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Evaluation the effect of Nigella Sativa oil on Acute Ischemic Stroke Outcome: A triple blind randomized placebo controlled trial
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Public title
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Effect of Nigella sativa oil on Prognosis of Acute Ischemic Stroke Patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Acute ischemic stroke hospitalization in Shahid Beheshti hospital
Not having a severe disability after stroke(NIHSS<20)
Not to receive antioxidants (such as vitamin C and E) constantly
Not affected by AIDS and neurodegenerative diseases (e.g. Alzheimer's, Parkinson's, amyotrophic lateral sclerosis
Exclusion criteria:
Request of patients to Exit from the study;
Previous chronic disease interferes with the performance evaluation in patients such as: chronic infections, liver or kidney failure, cancers;
Residual weakness of previous stroke
Pregnancy or breastfeeding or any conditions that makes follow up impossible
Sever loss of Consciousness
Thrombolytic therapy
Endarterectomy
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Age
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From 40 years old to 100 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients were randomly allocated into two groups using random numbers table developed by Random Allocation Software
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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In this study, patients, statistical analyst and physicians are not aware of the allocation of drugs and placebo, and someone outside the group is aware of the allocation of treatment
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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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2018-12-04, 1397/09/13
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Ethics committee reference number
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IR.MUQ.REC.1397.135
Health conditions studied
1
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Description of health condition studied
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Acute 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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Prognosis after stroke
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Timepoint
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At hospitalization(0), discharge(1), and after 3 months(2)
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Method of measurement
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Functional status score based on NIHSS (National institutes of health stroke scale)(at least 50% reduction in NIHSS score in 3-month compared to the baseline score
Secondary outcomes
1
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Description
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Prognosis after stroke
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Timepoint
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At hospitalization(0), discharge(1), and after 3 months(2)
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Method of measurement
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Modified Rankin scale (MRS)
Intervention groups
1
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Description
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Intervention group:The group used Nigella Sativa oil capsules amount 3 gram for 3 months, every day
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Category
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Treatment - Drugs
2
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Description
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Control group: The group used placebo capsules amount 3 gram for 3 months, every day
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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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Ghoum 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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With attention due to the type of study and publication of the article, there was no need to mention this
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is 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
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Title and more details about the data/document
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With attention due to the type of study and publication of the article, there was no need to mention this
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When the data will become available and for how long
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With attention due to the type of study and publication of the article, there was no need to mention this
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To whom data/document is available
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With attention due to the type of study and publication of the article, there was no need to mention this
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Under which criteria data/document could be used
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With attention due to the type of study and publication of the article, there was no need to mention this
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From where data/document is obtainable
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With attention due to the type of study and publication of the article, there was no need to mention this
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What processes are involved for a request to access data/document
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With attention due to the type of study and publication of the article, there was no need to mention this
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Comments
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With attention due to the type of study and publication of the article, there was no need to mention this