The effect of crocin (aqueous extract of saffron) on the serum changes of neurogenesis and apoptosis biomarkers in patients with cerebral ischemic stroke
The current study aimed at proving or rejecting the neuroprotective hypothesis of saffron in stroke patients.
Design
Patients were randomly assigned in two groups of control and case groups using Simple Randomization technique. In this study, blindness was not done. Eventually, 60 patients would be selected.
Settings and conduct
here, patients with ischemic stroke are studied who are referred to Emergency Hospital of Imam Hossein (AS) and admitted in the department of neurology . The demographic data of all patients will be recorded in the form presented in the appendix. Neurological examinations will be carried out daily on the days of hospitalization.The NHHS of the patients of both groups will be calculated and recorded in two times, the first and forth day. Blood samples will be also taken to measure BDNF, S100, C-FOS in the morning of the first day of admission before taking medication and in the morning of the forth day (discharge).
Participants/Inclusion and exclusion criteria
In this randomized clinical trial, patients with ischemic stroke in the Middle Cerebral Artery (MCA) range with NIHSS: 5-20 have been referred to Emergency Hospital of Imam Hossein Hospital and admitted to the department of neurology.
Intervention groups
The case group will receive the capsules containing aqueous extract of saffron with a dose of 300 mg (100 mg / TDS) in the acute stroke phase (the first 4 days when the patient is hospitalized) with a routine regimen of cerebral ischemic stroke (including an antiplatelet or anticoagulant drug with atorvastatin). The control group will only take the mentioned routine pharmaceutical regimen.
The effect of crocin (aqueous extract of saffron) on the serum changes of neurogenesis and apoptosis biomarkers in patients with cerebral ischemic stroke
Public title
The evaluation of saffron's effect in patients with stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with ischemic stroke (NIHSS Score: 5-20) who have had brain trauma for less than 24 hours, whose stroke has been defined within the range Middle Cerebral Artery (MCA) based on clinical examination and brain imaging (CT scan or MRI) and who are admitted to the Neurology or Emergency Department of Imam Hossein Hospital could be entered into the study.
Exclusion criteria:
Intolerance to the drug
Hemorrhagic stroke
NIHSS> 20 during hospitalization
Acute and chronic renal failure (renal failure, stages 4 and 5)
Acute failure or acute liver disease (Stage B and C failure)
A history of disability before the current stroke
Acute ischemic heart disease during the last 48 hours
A history of Alzheimer's disease or other types of dementia
History of receiving drugs that have neuroprotective properties for the last 6 months
Trombolysis (tPA)
CNS tumor
A recent trauma to the head
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Poursina, 16 Azar St., Tehran.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-12-10, 1396/09/19
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4182
Health conditions studied
1
Description of health condition studied
Ischemic stroke
ICD-10 code
G46.3*
ICD-10 code description
Brain stem stroke syndrome
Primary outcomes
1
Description
Barthel Index: It is a questionnaire for monitoring the patient's ability after stroke. National Institutes of Health Stroke Scale (NIHSS): it is a questionnaire based on an examination to estimate the severity of stroke. Serum BDNF (Brain-derived neurotrophic factor) level: It is a neurogenesis marker in the brain and its serum level is measurable and predictive of damage to these tissues. Protein S100: it is from a group of proteins bound with calcium and considered as a bio-marker of tissue damage in the brain. Serum C-FOS Level: It is the c-Fos proto-oncogene in the brain, whose long-term induction of ischemia leads to the production of apoptotic genes which kill the cell.
Timepoint
The first day of hospitalization and the fourth day of admission to the hospital. Barthel test is done three months after discharge.
Method of measurement
Barthel test: questionnaire, NIHSS scale: questionnaire, BDNF, protein 100: ELISA technique, c-Fos: Western blot.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They will receive capsules containing aqueous extract of saffron with a dose of 300 mg (100 mg / TDS) in the acute stroke phase (the first 4 days in which the patient is admitted) along with a routine regimen of ischemic stroke (including antiplatelet or anti-coagulant medication plus atorvastatin). Up to three months after discharge, they will daily receive capsules of saffron at a dose of 100 mg (50 mg / BD) in addition to the routine drugs. In order to prepare the capsules, Saffron stigmas were purchased from Talakaran-e-Mazraeh Co., (Torbate-Heydarieh, South Khorasan, Iran) and delivered to the Niak Darou Co., Tehran, Iran for aqueous extraction. The extract was then enrolled in the capsules containing 50 mg of saffron extract. The analysis of the extract showed that it contains 20 % crocin, which was used as the base for filling capsules. Saffron delivery is done based on the crocin content in each capsule.
Category
Treatment - Drugs
2
Description
Control group: this group will only take the routine pharmaceutical regimen. The routine regimen of ischemic stroke is including antiplatelet or anti-coagulant medication plus atorvastatin.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
بخش مغز و اعصاب بیمارستان امام حسین
Full name of responsible person
Mostafa Asadollahi
Street address
Tehran Province, Tehran, District 7, Madani Street
City
Tehran
Province
Tehran
Postal code
7343 3000
Phone
+98 21 7343 3000
Email
info@ehmc.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Seyed Shahabeddin Sadr
Street address
End of Blvd.Khosvarz, Northern Side of the Eastern Side of the Imam Khomeini Hospital, Neural Rehabilitation Center (Reyhaneh), Third Floor, Electrophysiological Research Center
City
Tehran
Province
Tehran
Postal code
3439123900
Phone
+98 21 6658 1560
Fax
+98 21 6658 1560
Email
shahabsadr2002@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mostafa Asadollahi1
Position
Non-faculty specialist
Latest degree
Specialist
Other areas of specialty/work
Others
Street address
Electrophysiological Research Center, The northern Side of the Eastern Side of the, Neural Rehabilitation Center (Reyhaneh), Imam Khomeini Hospital, End of Blvd.Khosvarz
City
Tehran
Province
Tehran
Postal code
3439123900
Phone
+98 21 6658 1560
Email
mos.asadollahi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Gila Pirzad Jahromi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Baqiyatallah University of Medical Sciences, Mulla Sadra St
City
Tehran
Province
Tehran
Postal code
19568-37173
Phone
+98 21 8862 0817
Email
g_pirzad_jahromi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Gila Pirzad Jahromi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Baqiyatallah University of Medical Sciences, Mulla Sadra St
City
Tehran
Province
Tehran
Postal code
19568-37173
Phone
+98 21 8862 0817
Email
g_pirzad_jahromi@yahoo.com
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
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data can be shared after making the participants unidentifiable.
When the data will become available and for how long
Available 6 months after printing the results.
To whom data/document is available
The researchers working in the academic and scientific institutes and pharmacies.
Under which criteria data/document could be used
In order to produce medicine and write overview articles
From where data/document is obtainable
Gila Pirzad Jahromi
Neuroscience Research Centre, Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheikh Bahayi Ave, Mulla Sadra St, Vanak Square,
POBox: 19568-37173
Telephone: 00982188620817
Email: g_pirzad_jahromi@yahoo.com
Cell Phone: 98-912-509-0473
What processes are involved for a request to access data/document