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Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: hossein saghafi
Full name of responsible person - Persian: حسین ثقفی
Street address - English: Namber 83, Alley 4, Alley 1.1, Safashahr Street
Street address - Persian: خیابان صفاشهر، کوچه 1/1، کوچه شماره 4، پلاک 83
City - English: qom
City - Persian: قم
Province: Ghoum
Country: Iran (Islamic Republic of)
Postal code: 3716987366
Phone: +98 25 3285 2720
Fax:
Email: driran1399@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hossein Saghafi
Full name of responsible person - Persian: حسین ثقفی
Street address - English: Namber 83, Alley 4, Alley 1.1, Safashahr Street
Street address - Persian: خیابان صفاشهر، کوچه 1/1، کوچه شماره 4، پلاک 83
City - English: Qom
City - Persian: قم
Province: Ghoum
Country: Iran (Islamic Republic of)
Postal code: 3716987366
Phone: +98 25 3285 2720
Fax:
Email: driran1399@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: hossein saghafiHossein Saghafi Full name of responsible person - Persian: حسین ثقفی Street address - English: Namber 83, Alley 4, Alley 1.1, Safashahr Street Street address - Persian: خیابان صفاشهر، کوچه 1/1، کوچه شماره 4، پلاک 83 City - English: qomQom City - Persian: قم Province: Ghoum Country: Iran (Islamic Republic of) Postal code: 3716987366 Phone: +98 25 3285 2720 Fax: Email: driran1399@gmail.com Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Muhammad Hossein Yusefi
Full name of responsible person - Persian: محمد حسین یوسفی
Position - English: Student
Position - Persian: دانشجو
Latest degree: bachelor
Area of specialty/work:
Area of specialty/work title - English: Neuroscience
Area of specialty/work title - Persian: علوم اعصاب
Street address - English: Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
Street address - Persian: ایران، قم، میدان آزادگان، بلوار شهید بهشتی، بیمارستان فوق تخصصی شهید بهشتی -واحد توسعه تحقیقات بالینی
City - English: Qom
City - Persian: قم
Province: Ghoum
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3713649373
Phone: +98 25 3886 0146
Mobile: +98 910 137 4670
Fax:
Email: driran1390@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ehsan Sharifipour
Full name of responsible person - Persian: احسان شریفی پور
Position - English: Professor assistant
Position - Persian: استادیار
Latest degree: specialist
Area of specialty/work: 86
Area of specialty/work title - English:
Area of specialty/work title - Persian: علوم اعصاب
Street address - English: Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
Street address - Persian: ایران، قم، میدان آزادگان، بلوار شهید بهشتی، بیمارستان فوق تخصصی شهید بهشتی -واحد توسعه تحقیقات بالینی
City - English: Qom
City - Persian: قم
Province: Ghoum
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3713649373
Phone: +98 25 3886 0146
Mobile: +98 910 137 4670
Fax:
Email: ehsansharifipoor@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Muhammad Hossein YusefiEhsan Sharifipour Full name of responsible person - Persian: محمد حسین یوسفیاحسان شریفی پور Position - English: StudentProfessor assistant Position - Persian: دانشجواستادیار Latest degree: bachelorspecialist Area of specialty/work: 86 Area of specialty/work title - English: Neuroscience Area of specialty/work title - Persian: علوم اعصاب Street address - English: Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran Street address - Persian: ایران، قم، میدان آزادگان، بلوار شهید بهشتی، بیمارستان فوق تخصصی شهید بهشتی -واحد توسعه تحقیقات بالینی City - English: Qom City - Persian: قم Province: Ghoum Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 3713649373 Phone: +98 25 3886 0146 Mobile: +98 910 137 4670 Fax: Email: driran1390ehsansharifipoor@yahoo.com Web page address:
Protocol summary
Study aim
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.
Design
A randomized controlled clinical trial and triple blind, parallel study
Settings and conduct
This study is conducted at Shahid Beheshti Hospital in Qom and is blinded by placebo
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Disability of patients
General information
Reason for update
Acronym
AEH
IRCT registration information
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
Registration date
2019-01-05, 1397/10/15
Registrant information
Name
Hossein Yusefi
Name of organization / entity
Qom University of medical science
Country
Iran (Islamic Republic of)
Phone
+98 25 3886 0146
Email address
driran1399@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Nigella Sativa oil on Acute Ischemic Stroke Outcome: A triple blind randomized placebo controlled trial
Public title
Effect of Nigella sativa oil on Prognosis of Acute Ischemic Stroke Patients
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 40 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly allocated into two groups using random numbers table developed by Random Allocation Software
Blinding (investigator's opinion)
Triple blinded
Blinding description
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
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
Vice chancellor for research of Qom University of Medical Sciences, Safashar road, Qom, Iran
City
Qom
Province
Ghoum
Postal code
87366-37169
Approval date
2018-12-04, 1397/09/13
Ethics committee reference number
IR.MUQ.REC.1397.135
Health conditions studied
1
Description of health condition studied
Acute ischemic stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Prognosis after stroke
Timepoint
At hospitalization(0), discharge(1), and after 3 months(2)
Method of measurement
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
Description
Prognosis after stroke
Timepoint
At hospitalization(0), discharge(1), and after 3 months(2)
Method of measurement
Modified Rankin scale (MRS)
Intervention groups
1
Description
Intervention group:The group used Nigella Sativa oil capsules amount 3 gram for 3 months, every day
Category
Treatment - Drugs
2
Description
Control group: The group used placebo capsules amount 3 gram for 3 months, every day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Ehsan Sharifipour
Street address
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3886 0146
Email
Ehsansharifipoor@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hossein Saghafi
Street address
Namber 83, Alley 4, Alley 1.1, Safashahr Street
City
Qom
Province
Ghoum
Postal code
3716987366
Phone
+98 25 3285 2720
Email
driran1399@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Ehsan Sharifi Pour
Position
Professor assistant
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 253886016
Email
driran1399@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Ehsan Sharifipour
Position
Professor assistant
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3886 0146
Email
ehsansharifipoor@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Muhammad Hossein Yusefi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Neuroscience
Street address
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 910 137 4670
Email
driran1390@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
With attention due to the type of study and publication of the article, there was no need to mention this
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
With attention due to the type of study and publication of the article, there was no need to mention this
When the data will become available and for how long
With attention due to the type of study and publication of the article, there was no need to mention this
To whom data/document is available
With attention due to the type of study and publication of the article, there was no need to mention this
Under which criteria data/document could be used
With attention due to the type of study and publication of the article, there was no need to mention this
From where data/document is obtainable
With attention due to the type of study and publication of the article, there was no need to mention this
What processes are involved for a request to access data/document
With attention due to the type of study and publication of the article, there was no need to mention this
Comments
With attention due to the type of study and publication of the article, there was no need to mention this