Protocol summary
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Study aim
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The current study aimed at proving or rejecting the neuroprotective hypothesis of saffron in stroke patients.
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Design
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All patients with ischemic stroke will be randomly divided into the control and saffron groups. In this study, blindness is not performed. Finally, 60 patients will be selected.
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Settings and conduct
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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 NIHS 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 oxidative stress biomarkers in the morning of the first day of admission before taking medication and in the morning of the forth day (discharge).
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Participants/Inclusion and exclusion criteria
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In this randomized clinical trial, patients with ischemic stroke in the Middle Cerebral Artery range with NIHSS: 5-20 have been referred to Emergency Hospital of Imam Hossein Hospital and admitted to the department of neurology.
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Intervention groups
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The case group will receive the capsules containing aqueous extract of saffron with a dose of 200 mg twice per day plus a routine regimen of cerebral ischemic stroke (including an antiplatelet or anticoagulant drug with atorvastatin) during the four days of hospitalization after the stroke. The control group will only take the mentioned routine pharmaceutical regimen.
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Main outcome variables
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Ischemic stroke; Saffron; NIHSS; oxidative stress
General information
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Reason for update
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The plan expanded to measure new oxidative stress biomarkers. Therefore, these biomarkers will be measured in serum prepared from stroke patients.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180806040716N1
Registration date:
2018-10-24, 1397/08/02
Registration timing:
retrospective
Last update:
2020-05-01, 1399/02/12
Update count:
1
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Registration date
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2018-10-24, 1397/08/02
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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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2017-12-16, 1396/09/25
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Expected recruitment end date
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2018-07-16, 1397/04/25
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Actual recruitment start date
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2017-12-16, 1396/09/25
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Actual recruitment end date
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2018-07-16, 1397/04/25
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Trial completion date
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2018-08-16, 1397/05/25
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Scientific title
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The effect of aqueous extract of saffron on antioxidant defense system in stroke patients
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Public title
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The evaluation of saffron effect in patients with stroke
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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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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No information
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Sample size
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Target sample size:
60
Actual sample size reached:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple Randomization
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Other
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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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2018-05-14, 1397/02/24
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Ethics committee reference number
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IR.BMSU.REC.1397.028
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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G46.3*
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ICD-10 code description
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Brain stem stroke syndrome
Primary outcomes
1
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Description
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National Institutes of Health Stroke Scale (NIHSS) is a questionnaire based on an examination to estimate the severity of stroke. Cellular enzymatic and non-enzymatic antioxidant defense system include superoxide dismutase (SOD), catalase (CAT), glutathione S-transferase (GST), glutathione peroxidase (GPx) and glutathione reductase (GR) and GSH, which act as free radical scavenger. Malondialdehyde (MDA) is an end-product of lipid peroxidation, which occurs due to the oxidation of polyunsaturated fatty acid side chains of membranes leading to a change in their functional properties level. Measurement of total antioxidant capacity (TAC) evaluates the efficiency and ability of all antioxidants present in biological fluids to protect against oxidative damage to membranes and other cellular components.
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Timepoint
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The first day of hospitalization and the fourth day of admission to the hospital.
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Method of measurement
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NIHSS scale: questionnaire, Oxidative stress biomarkers including SOD, CAT, GST, GPx and GR activities, GSH, TAC and MDA levels will be measured by biochemical methods manually or using kits.
Intervention groups
1
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Description
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Intervention group: They will receive capsules containing aqueous extract of saffron with a dose of 200 mg twice per day 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). 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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
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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Bagheiat-allah 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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Yes - There is 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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Yes - There is 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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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Data can be shared after making the participants unidentifiable.
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When the data will become available and for how long
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Available 6 months after printing the results.
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To whom data/document is available
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The researchers working in the academic and scientific institutes and pharmacies.
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Under which criteria data/document could be used
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In order to produce medicine and write overview articles
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From where data/document is obtainable
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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
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What processes are involved for a request to access data/document
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Request by phone or email
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Comments
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