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IRCT20180806040716N1 IRCT 2018-10-24 Bagheiat-allah University of Medical Sciences The evaluation of saffron effect in patients with stroke The effect of aqueous extract of saffron on antioxidant defense system in stroke patients 2017-12-16 anticipated 60 Complete https://irct.ir/trial/33085 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Simple Randomization. N/A Ischemic stroke. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information.
public Mostafa Asadollahi1
Electrophysiological Research Center, The northern Side of the Eastern Side of the, Neural Rehabilitation Center (Reyhaneh), Imam Khomeini Hospital, End of Blvd.Khosvarz
Tehran Iran (Islamic Republic of) 3439123900 +98 21 6658 1560 mos.asadollahi@gmail.com Tehran University of Medical Sciences scientific Gila Pirzad Jahromi
Baqiyatallah University of Medical Sciences, Mulla Sadra St
Tehran Iran (Islamic Republic of) 19568-37173 +98 21 8862 0817 g_pirzad_jahromi@yahoo.com Baqiyatallah University of Medical Sciences Iran (Islamic Republic of) 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. no limit no limit Both 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 G46.3* Brain stem stroke syndrome Treatment - Drugs Treatment - Drugs 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. 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. 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. Timepoint: The first day of hospitalization and the fourth day of admission to the hospital. Method of measurement: 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. Bagheiat-allah University of Medical Sciences Approved 2018-05-14 Ethics Committee of Baqiyatallah University of Medical Sciences Baqiyatallah University of Medical Sciences, Vanak Sq., Molla-Sadra street Tehran Tehran Iran (Islamic Republic of)