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The effect of aqueous extract of saffron on antioxidant defense system in stroke patients

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History
# Registration date Revision Id
2 2019-11-11, 1398/08/20 132061
1 2018-10-24, 1397/08/02 64453
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  • Protocol summary

    مطالعه حاضر با هدف اثبات یا رد فرضیه های عصبی حفاظتی زعفران در بیماران سکته مغزی انجام شده است.
    مطالعه حاضر با هدف اثبات یا رد فرضیه های حفاظت عصبی زعفران در بیماران سکته مغزی انجام شده است.
    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.
    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.
    بیماران با روش تصادفي ساده در دو گروه کنترل و گروه نمونه جاي میگیرند. در این مطالعه کور سازی انجام نمی شود. در نهایت 60 بیمار انتخاب می شود.
    بیماران با روش تصادفي ساده در دو گروه کنترل و گروه زعفران جاي خواهند گرفت. در این مطالعه کور سازی انجام نمی شود. در نهایت 60 بیمار انتخاب خواهد شد.
    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).
    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).
    مطالعه بر روی بیماران مبتلا به سکته ایسکمیک مغزي که به اورژانس بيمارستان امام حسين (ع) مراجعه نموده و در بخش نورولوژی این مرکر بستری گردیده اند، انجام خواهد شد.بود.اطلاعات دموگرافیک تمام بیماران در فرمی که در قسمت ضمیمه آورده شده ثبت خواهد شد. معاینات نورولوژیک طی روزهای بستری بیماران به طور روزانه انجام خواهد شد. NHHSSبیماران در دو گروه، دو مرتبه یکی روز اول و دیگری روز چهارم، محاسبه و ثبت خواهد گردید. نمونه های خون جهت اندازه گیری BDNF ,S100 ,C-FOS در صبح روز اول بستری قبل از دریافت داروها و صبح روز چهارم (ترخیص) گرفته می شود.
    مطالعه بر روی بیماران مبتلا به سکته ایسکمیک مغزي که به اورژانس بيمارستان امام حسين (ع) مراجعه نموده و در بخش نورولوژی این مرکر بستری گردیده اند، انجام خواهد شد. اطلاعات دموگرافیک تمام بیماران در فرمی که در قسمت ضمیمه آورده شده ثبت خواهد شد. معاینات نورولوژیک طی روزهای بستری بیماران به طور روزانه انجام خواهد شد. NIHSS بیماران در دو گروه، دو مرتبه یکی روز اول و دیگری روز چهارم، محاسبه و ثبت خواهد گردید. نمونه های خون جهت اندازه گیری بیومارکرهای استرس اکسیداتیو در صبح روز اول بستری قبل از دریافت داروها و صبح روز چهارم (ترخیص) گرفته می شود.
    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.
    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.
    افراد مورد بررسي در اين كار آزمايي بالینی تصادفي، بيماران مبتلا به سکته ايسکميک مغزی در محدوده Middle Cerebral Artery (MCA) با NIHSS: 5-20 هستند که به اورژانس بيمارستان امام حسين (ع) مراجعه نموده و در بخش نورولوژی این مرکر بستری گردیده اند.
    افراد مورد بررسي در اين كار آزمايي بالینی تصادفي، بيماران مبتلا به سکته ايسکميک مغزی در محدوده Middle Cerebral Artery با NIHSS: 5-20 هستند که به اورژانس بيمارستان امام حسين (ع) مراجعه نموده و در بخش نورولوژی این مرکر بستری گردیده اند.
    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 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.
    گروه case کپسولهای محتوی عصاره آبی زعفران با دوز 300 میلی گرم(( 100mg/TDS)در فاز حاد استروک (شامل 4 روز اول که بیمار در بخش بستری است) بهمراه رژيم دارويي روتين سکته ایسکمیک مغزی (شامل داروی آنتی پلاکت یا آنتی کوآگولان به همراه آتوروستاتین ) را دریافت خواهند کرد و گروه کنترل فقط رژيم دارويي روتين ذکر شده را خواهند گرفت.
    گروه case کپسولهای محتوی عصاره آبی زعفران با دوز 200 میلی گرم دو بار در روز بهمراه رژيم دارويي روتين سکته ایسکمیک مغزی (شامل داروی آنتی پلاکت یا آنتی کوآگولان به همراه آتوروستاتین ) در طی 4 روز اول بستری بیمار ان در بخش بعد از سکته مغزی را دریافت خواهند کرد. گروه کنترل فقط رژيم دارويي روتين ذکر شده را خواهند گرفت.
    Ischemic stroke; NIHSS; Neuroprotection; Barthel Index; Crocus Sativus (Saffron);BDNF(Brain-derived neurotrophic factor); S-100;C-FOS
    Ischemic stroke; Saffron; NIHSS; oxidative stress
    NIHSS; Barthel Index;Serum BDNF Level;Serum C-FOS Level;Serum S100 Leve;سکته ایسکمی; عصاره زعفران
    NIHSS; سکته ایسکمی مغزی; زعفران; استرس اکسیداتیو

  • General information

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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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    طرح روی سنجش بیومارکرهای استرس اکسیداتیو گسترش یافت. بنابر این این بیومارکرها در سرمهای تهیه شده از بیماران سکته مغزی اندازه گیری خواهد شد.
    The evaluation of saffron's effect in patients with stroke
    The evaluation of saffron effect in patients with stroke
    The effect of crocin (aqueous extract of saffron) on the serum changes of neurogenesis and apoptosis biomarkers in patients with cerebral ischemic stroke
    The effect of aqueous extract of saffron on antioxidant defense system in stroke patients
    بررسی اثر درمانی کروسین (عصاره آبی زعفران) بر تغییرات سرمی بیو مارکرهای نورون زایی و آپوپتوزیس در بیماران سکته ایسکمیک مغزی
    بررسی اثر درمانی عصاره آبی زعفران بر سیستم دفاعی آنتی اکسیدان در بیماران سکته مغزی

  • Ethics committees

    #1
    2017-12-10, 1396/09/19
    2018-05-14, 1397/02/24
    IR.TUMS.VCR.REC.1396.4182
    IR.BMSU.REC.1397.028

  • Primary outcomes

    #1
    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.
    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.
    تست بارتل: پرسشنامه ای جهت پایش تلفنی میزان توانایی بیمار بعد از سکته مغزی، مقیاس سکته مغزی موسسه های ملی بهداشت و درمان (NIHSS)، فاکتور نوروتروفی مشتق شده از مغز(BDNF): مارکر نوروژنزیس در مغزو سطح سرمی آن در آسیب این بافتها قابل اندازه گیری و دارای ارزش پیش گویی کننده است. پروتئین اس100 از گروه پروتئین های باند شونده با کلسیم و به عنوان بیو مارکر آسیب بافتی در مغز ، پروتئین سی فاس: پروتوانکوژن c-Fos در مغز که القاء طولانی مدت آن پس از ایسکمی منجر به ایجاد ژنهای آپوپتوتیک می شود که باعث مرگ سلول می شود.
    مقیاس سکته مغزی موسسه های ملی بهداشت و درمان (NIHSS) پرسشنامه ای است که براساس معاینه برای تخمین شدت سكته مغزی ساخته شده است. سیستم دفاع آنتی اکسیدانی آنزیمی و غیر آنزیمی سلولی شامل سوپراکسید دیسموتاز (SOD)، کاتالاز (CAT)، گلوتاتیون S- ترانسفراز (GST)، گلوتاتیون پراکسیداز (GPx) و گلوتاتیون ردوکتاز (GR) و گلوتاتیون (GSH) است که به عنوان پاکساز رادیکالهای آزاد عمل می کنند. مالون دی آلدئید (MDA) محصول نهایی پراکسیداسیون لیپید است که به دلیل اکسیداسیون زنجیره های جانبی اسید چرب غیر اشباع غشاء و فرآیندهای غشایی منجر به تغییر در سطح خصوصیات عملکردی آنها می شود. اندازه گیری ظرفیت آنتی اکسیدانی کل (TAC) کارایی و توانایی همه آنتی اکسیدان های موجود در مایعات بیولوژیکی را برای محافظت در برابر آسیب اکسیداتیو به غشاها و سایر اجزای سلولی ارزیابی می کند.
    The first day of hospitalization and the fourth day of admission to the hospital. Barthel test is done three months after discharge.
    The first day of hospitalization and the fourth day of admission to the hospital.
    روز اول بستری و روز چهارم بستری در بیمارستان. تست بارتل سه ماه بعد از ترخیص
    روز اول بستری و روز چهارم بستری در بیمارستان.
    Barthel test: questionnaire, NIHSS scale: questionnaire, BDNF, protein 100: ELISA technique, c-Fos: Western blot.
    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.
    تست بارتل: پرسشنامه ، مقیاس NIHSS: پرسشنامه، فاکتور نوروتروفی مشتق شده از مغز (BDNF) و پروتئین اس100: تکنیک الایزا، پروتئین سی فاس: تکنیک وسترن بلات
    مقیاس NIHSS: پرسشنامه، بیومارکرهای استرس اکسیداتیو شامل فعالیت آنزیمهای SOD، CAT، GST، GPx و GR، غلظت GSH ،TAC و MDA توسط روشهای بیوشیمیایی به صورت دستی و یا با استفاده از کیتها اندازه گیری خواهند شد.

  • Intervention groups

    #1
    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.
    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.
    گروه مداخله: کپسولهای محتوی عصاره آبی زعفران با دوز 300 میلی گرم ((100 mg/TDS) در فاز حاد استروک (شامل 4 روز اول که بیمار در بخش بستری است) بهمراه رژيم دارويي روتين سکته ایسکمیک مغزی (شامل داروی آنتی پلاکت یا آنتی کوآگولان به همراه آتوروستاتین ) را دریافت خواهند کرد و سپس تا سه ماه پس از ترخیص، علاوه بر داروهای روتین، کپسول زعفران با دوز100 میلیگرم روزانه (50 mg/BD) را دریافت خواهند کرد. برای تهیه کپسولها، کلاله های زعفران از شرکت طلاکاران مزرعه (تربت حیدریه، جنوب خراسان ایران) خریداری شده و به منظور استخراج عصاره آبی به شرکت نیاک دارو تهران تحویل داده شد. عصاره در کپسول های حاوی 50 میلی گرم عصاره زعفران ثبت شد. تجزیه و تحلیل عصاره نشان داد که کپسولهای 50 میلی گرمی حاوی 20 درصد کروسین بوده که به عنوان پایه ای برای پر کردن کامل کپسول استفاده می شد.
    گروه مداخله: آنها کپسولهای محتوی عصاره آبی زعفران با دوز 200 میلی گرم دو بار در روز در فاز حاد سکته مغزی (شامل 4 روز اول که بیمار در بخش بستری است) بهمراه رژيم دارويي روتين سکته ایسکمیک مغزی (شامل داروی آنتی پلاکت یا آنتی کوآگولان به همراه آتوروستاتین ) را دریافت خواهند کرد برای تهیه کپسولها، کلاله های زعفران از شرکت طلاکاران مزرعه (تربت حیدریه، جنوب خراسان ایران) خریداری شده و به منظور استخراج عصاره آبی به شرکت نیاک دارو تهران تحویل داده شد. عصاره در کپسول های حاوی 50 میلی گرم عصاره زعفران ثبت شد. تجزیه و تحلیل عصاره نشان داد که کپسولهای 50 میلی گرمی حاوی 20 درصد کروسین بوده که به عنوان پایه ای برای پر کردن کامل کپسول استفاده می شد.
    #2
    گروه کنترل: فقط رژيم دارويي روتين را خواهند گرفت. رژيم دارويي روتين سکته ایسکمیک مغزی شامل داروی آنتی پلاکت یا آنتی کوآگولان به همراه آتوروستاتین می باشد.
    گروه کنترل: فقط رژيم دارويي روتين را خواهند گرفت. رژيم دارويي روتين سکته ایسکمیک مغزی شامل داروی آنتی پلاکت یا آنتی کوآگولان به همراه آتوروستاتین می باشد.

  • Recruitment centers

    #1
    Name of recruitment center - English: بخش مغز و اعصاب بیمارستان امام حسین
    Name of recruitment center - Persian: The neurology department of Imam Hussein Hospital
    Full name of responsible person - English: Mostafa Asadollahi
    Full name of responsible person - Persian: مصطفی اسداللهی
    Street address - English: Tehran Province, Tehran, District 7, Madani Street
    Street address - Persian: استان تهران، خیابان مدنی، ناحیه 7، تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 7343 3000
    Phone: +98 21 7343 3000
    Fax:
    Email: info@ehmc.ir
    Web page address:
    Name of recruitment center - English: The neurology department of Imam Hussein Hospital
    Name of recruitment center - Persian: بخش مغز و اعصاب بیمارستان امام حسین (ع)
    Full name of responsible person - English: Mostafa Asadollahi
    Full name of responsible person - Persian: مصطفی اسداللهی
    Street address - English: Madani Street, District 7, Tehran
    Street address - Persian: تهران، ناحیه 7، خیابان مدنی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 7343 3000
    Phone: +98 21 7343 3000
    Fax:
    Email: info@ehmc.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Seyed Shahabeddin Sadr
    Full name of responsible person - Persian: دکتر سید شهاب الدین صدر
    Street address - English: End of Blvd.Khosvarz, Northern Side of the Eastern Side of the Imam Khomeini Hospital, Neural Rehabilitation Center (Reyhaneh), Third Floor, Electrophysiological Research Center
    Street address - Persian: انتهای بلوارکشاورز،ضلع شمالی درب شرقی مجتمع بیمارستان امام خمینی (ره)، ساختمان پژوهشکده بازتوانی عصبی (ریحانه) طبقه سوم مرکز تحقیقات الکتروفیزیولوژی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 3439123900
    Phone: +98 21 6658 1560
    Fax: +98 21 6658 1560
    Email: shahabsadr2002@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Mahvash Jafari
    Full name of responsible person - Persian: دکتر مهوش جعفری
    Street address - English: Department of Biochemistry, Faculty of Medicine, Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheikh Bahayi Ave, Mulla Sadra St, Vanak Square,
    Street address - Persian: میدان ونک -خیابان ملاصدرا-خیابان شیخ بهایی جنوبی- خیابان نصرتی-دانشگاه علوم پزشکی بقیه الله (عج)، دانشکده پزشکی، گروه بیوشیمی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 14359-16471
    Phone: +98 21 8248 5424
    Fax: +98 21 8862 0843
    Email: m.jafari145@gmail.com
    Web page address:
    Tehran University of Medical Sciences
    Bagheiat-allah University of Medical Sciences
    دانشگاه علوم پزشکی تهران
    دانشگاه علوم پزشکی بقیه الله

Protocol summary

Study aim
The current study aimed at proving or rejecting the neuroprotective hypothesis of saffron in stroke patients.
Design
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.
Settings and conduct
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).
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Ischemic stroke; Saffron; NIHSS; oxidative stress

General information

Reason for update
The plan expanded to measure new oxidative stress biomarkers. Therefore, these biomarkers will be measured in serum prepared from stroke patients.
Acronym
IRCT registration information
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
Registration date
2018-10-24, 1397/08/02
Registrant information
Name
Gila Pirzad Jahromi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 0817
Email address
dr.pirzad@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-16, 1396/09/25
Expected recruitment end date
2018-07-16, 1397/04/25
Actual recruitment start date
2017-12-16, 1396/09/25
Actual recruitment end date
2018-07-16, 1397/04/25
Trial completion date
2018-08-16, 1397/05/25
Scientific title
The effect of aqueous extract of saffron on antioxidant defense system in stroke patients
Public title
The evaluation of saffron 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 Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, Vanak Sq., Molla-Sadra street
City
Tehran
Province
Tehran
Postal code
14359-16471
Approval date
2018-05-14, 1397/02/24
Ethics committee reference number
IR.BMSU.REC.1397.028

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
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.

Secondary outcomes

empty

Intervention groups

1

Description
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.
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
The neurology department of Imam Hussein Hospital
Full name of responsible person
Mostafa Asadollahi
Street address
Madani Street, District 7, Tehran
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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr Mahvash Jafari
Street address
Department of Biochemistry, Faculty of Medicine, Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheikh Bahayi Ave, Mulla Sadra St, Vanak Square,
City
Tehran
Province
Tehran
Postal code
14359-16471
Phone
+98 21 8248 5424
Fax
+98 21 8862 0843
Email
m.jafari145@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Request by phone or email
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