The effects of resveratrol supplement on some mediator genes of immunity and inflammation, inflammatory factors, oxidative stress and clinical outcomes in hospitalized acute ischemic stroke patients with enteral feeding in intensive care unit: A randomized triple-blind placebo-controlled trial
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Protocol summary
A controlled, parallel-group, triple-blind, randomized, phase 3 clinical trial on 76 patients with acute ischemic stroke, randomized blocks
A controlled, parallel-group, triple-blind, randomized, phase 3 clinical trial on 60 patients with acute ischemic stroke, randomized blocks
A controlled, parallel-group, triple-blind, randomized, phase 3 clinical trial on 7660 patients with acute ischemic stroke, randomized blocks
کارآزمایی بالینی دارای گروه کنترل، با گروههای موازی، سه سویه کور، تصادفی شده، فاز 3 بر روی 76 بیمار مبتلا به سکته ی مغزی حاد ایسکمیک، تصادفیسازی با استفاده از بلوکهای تصادفی
کارآزمایی بالینی دارای گروه کنترل، با گروههای موازی، سه سویه کور، تصادفی شده، فاز 3 بر روی 60 بیمار مبتلا به سکته ی مغزی حاد ایسکمیک، تصادفیسازی با استفاده از بلوکهای تصادفی
کارآزمایی بالینی دارای گروه کنترل، با گروههای موازی، سه سویه کور، تصادفی شده، فاز 3 بر روی 7660 بیمار مبتلا به سکته ی مغزی حاد ایسکمیک، تصادفیسازی با استفاده از بلوکهای تصادفی
The study will take place at the Firouzgar Hospital. Patients will be randomly assigned to two groups: Resveratrol (containing 250 mg of resveratrol and 10 mg of grape skin extract) TDS (38 people); and placebo (containing maltodextrin, similar to resveratrol capsules)TDS (38 people) for 30 days. Stroke severity will be measured using the NIHSS Stroke Scale. At the beginning and end of the study, 10 cc of IV blood samples will be collected from participants. Mononuclear cells will be extracted from these samples to perform quantitative real-time PCR, and RNA will be extracted and converted into cDNA using a kit. Serum levels of IL-1β and IL-6 will be evaluated using a kit and ELISA method. The serum total antioxidant capacity and serum malondialdehyde level will be evaluated using a kit and calorimetric method. The researcher, the neurologist, individuals involved in blood collection and sample evaluation, and the person performing statistical analysis will all be blinded.
The study will take place at the Firouzgar Hospital. Patients will be randomly assigned to two groups: Resveratrol (containing 250 mg of resveratrol and 10 mg of grape skin extract) TDS (30 people); and placebo (containing maltodextrin, similar to resveratrol capsules)TDS (30 people) for 28 days. Stroke severity will be measured using the NIHSS Stroke Scale. At the beginning and end of the study, 10 cc of IV blood samples will be collected from participants. Mononuclear cells will be extracted from these samples to perform quantitative real-time PCR, and RNA will be extracted and converted into cDNA using a kit. Serum levels of IL-1β and IL-6 will be evaluated using a kit and ELISA method. The serum total antioxidant capacity and serum malondialdehyde level will be evaluated using a kit and calorimetric method. The researcher, the neurologist, individuals involved in blood collection and sample evaluation, and the person performing statistical analysis will all be blinded.
The study will take place at the Firouzgar Hospital. Patients will be randomly assigned to two groups: Resveratrol (containing 250 mg of resveratrol and 10 mg of grape skin extract) TDS (3830 people); and placebo (containing maltodextrin, similar to resveratrol capsules)TDS (3830 people) for 3028 days. Stroke severity will be measured using the NIHSS Stroke Scale. At the beginning and end of the study, 10 cc of IV blood samples will be collected from participants. Mononuclear cells will be extracted from these samples to perform quantitative real-time PCR, and RNA will be extracted and converted into cDNA using a kit. Serum levels of IL-1β and IL-6 will be evaluated using a kit and ELISA method. The serum total antioxidant capacity and serum malondialdehyde level will be evaluated using a kit and calorimetric method. The researcher, the neurologist, individuals involved in blood collection and sample evaluation, and the person performing statistical analysis will all be blinded.
محل انجام مطالعه بیمارستان فیروزگر است. بیماران بهصورت تصادفی به دو گروه دریافتکننده مکمل رزوراترول (38 نفر) یا دارونما (38 نفر) تقسیم خواهند شد. روزانه سه عدد کپسول رزوراترول حاوی 250 میلی گرم رزوراترول و 10 میلی گرم عصاره پوست انگور و یا سه عدد کپسول دارونما (حاوی نشاسته ذرت، مشابه با کپسول رزوراترول از نظر اندازه، شکل، بستهبندی، بو و طعم) را به مدت 30 روز تجویز می شود. شدت استروک با استفاده از مقیاس سنجش استروک NIHSS اندازهگیری خواهد شد. 10 سیسی نمونه خون وریدی در ابتدا و انتهای مطالعه از شرکتکنندگان جمعآوری و به منظور انجام quantitative real-time PCR، سلولهای تکهستهای و سپس RNA استخراج و با استفاده از کیت به cDNA تبدیل خواهد شد. سطح سرمی IL-1β و IL-6 با استفاده از کیت و به روش الایزا، ظرفیت تام آنتیاکسیدانی سرم و سطح سرمی مالوندیآلدهید با استفاده از کیت و به روش کالریمتری ارزیابی خواهد شد. محقق، پزشک متخصص نورولوژی، افرادی که در خونگیری و ارزیابی نمونهها مشارکت دارند و فردی که آنالیز آماری را انجام خواهد داد از قرار گرفتن فرد در گروه مداخله یا کنترل مطلع نخواهد بود.
محل انجام مطالعه بیمارستان فیروزگر است. بیماران بهصورت تصادفی به دو گروه دریافتکننده مکمل رزوراترول (30 نفر) یا دارونما (30 نفر) تقسیم خواهند شد. روزانه سه عدد کپسول رزوراترول حاوی 250 میلی گرم رزوراترول و 10 میلی گرم عصاره پوست انگور و یا سه عدد کپسول دارونما (حاوی نشاسته ذرت، مشابه با کپسول رزوراترول از نظر اندازه، شکل، بستهبندی، بو و طعم) را به مدت 28 روز تجویز می شود. شدت استروک با استفاده از مقیاس سنجش استروک NIHSS اندازهگیری خواهد شد. 10 سیسی نمونه خون وریدی در ابتدا و انتهای مطالعه از شرکتکنندگان جمعآوری و به منظور انجام quantitative real-time PCR، سلولهای تکهستهای و سپس RNA استخراج و با استفاده از کیت به cDNA تبدیل خواهد شد. سطح سرمی IL-1β و IL-6 با استفاده از کیت و به روش الایزا، ظرفیت تام آنتیاکسیدانی سرم و سطح سرمی مالوندیآلدهید با استفاده از کیت و به روش کالریمتری ارزیابی خواهد شد. محقق، پزشک متخصص نورولوژی، افرادی که در خونگیری و ارزیابی نمونهها مشارکت دارند و فردی که آنالیز آماری را انجام خواهد داد از قرار گرفتن فرد در گروه مداخله یا کنترل مطلع نخواهد بود.
محل انجام مطالعه بیمارستان فیروزگر است. بیماران بهصورت تصادفی به دو گروه دریافتکننده مکمل رزوراترول (3830 نفر) یا دارونما (3830 نفر) تقسیم خواهند شد. روزانه سه عدد کپسول رزوراترول حاوی 250 میلی گرم رزوراترول و 10 میلی گرم عصاره پوست انگور و یا سه عدد کپسول دارونما (حاوی نشاسته ذرت، مشابه با کپسول رزوراترول از نظر اندازه، شکل، بستهبندی، بو و طعم) را به مدت 3028 روز تجویز می شود. شدت استروک با استفاده از مقیاس سنجش استروک NIHSS اندازهگیری خواهد شد. 10 سیسی نمونه خون وریدی در ابتدا و انتهای مطالعه از شرکتکنندگان جمعآوری و به منظور انجام quantitative real-time PCR، سلولهای تکهستهای و سپس RNA استخراج و با استفاده از کیت به cDNA تبدیل خواهد شد. سطح سرمی IL-1β و IL-6 با استفاده از کیت و به روش الایزا، ظرفیت تام آنتیاکسیدانی سرم و سطح سرمی مالوندیآلدهید با استفاده از کیت و به روش کالریمتری ارزیابی خواهد شد. محقق، پزشک متخصص نورولوژی، افرادی که در خونگیری و ارزیابی نمونهها مشارکت دارند و فردی که آنالیز آماری را انجام خواهد داد از قرار گرفتن فرد در گروه مداخله یا کنترل مطلع نخواهد بود.
General information
76
60
7660
2023-08-22, 1402/05/31
2024-12-30, 1403/10/10
20232024-0812-2230 00:00:00
2025-04-20, 1404/01/31
2025-12-31, 1404/10/10
2025-0412-2031 00:00:00
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Due to the low number of eligible patients and lack of patient recruitment, the design will be multicentered. The study will be conducted in the Stroke ICU of Firoozgar Hospital, the Intensive Care Unit of Shohadaye Tajrish Hospital of Shahid Beheshti University of Medical Sciences, the Intensive Care Unit of Sina Hospital of Tehran University of Medical Sciences, and the Intensive Care Unit of Rasoul Akram Hospital. According to the studies, we reduce the duration of the intervention to 28 days. The sample size, with the calculation of 20% drop out of the study, will be 60 patients. The responsible person in Firouzgar Hospital changed. The percentage of financial support was incorrectly written as 26%, but it was corrected to 100%.
Due to the low number of eligible patients and lack of patient recruitment, the design will be multicentered. The study will be conducted in the Stroke ICU of Firoozgar Hospital, the Intensive Care Unit of Shohadaye Tajrish Hospital of Shahid Beheshti University of Medical Sciences, the Intensive Care Unit of Sina Hospital of Tehran University of Medical Sciences, and the Intensive Care Unit of Rasoul Akram Hospital. According to the studies, we reduce the duration of the intervention to 28 days. The sample size, with the calculation of 20% drop out of the study, will be 60 patients. The responsible person in Firouzgar Hospital changed. The percentage of financial support was incorrectly written as 26%, but it was corrected to 100%.
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به علت کم بودن بیماران واجد شرایط و عدم بیمارگیری طرح چند مرکزی شد و مطالعه در بخش ICU استروک بیمارستان فیروزگر، بخش مراقبت های ویژه بیمارستان شهدای تجریش دانشگاه علوم پزشکی شهید بهشتی، بخش مراقبت های ویژه بیمارستان سینا دانشگاه علوم پزشکی تهران, بخش مراقبت های ویژه بیمارستان رسول اکرم انجام خواهد شد. طول مدت مداخله با توجه به مطالعات به 28 روز کاهش یافت. حجم نمونه پیش بینی شده به 60 نفر تغییر یافت. فرد مسوول در بیمارستان فیروزگر تغییر یافت. درصد حمایت مالی به اشتباه 26 درصد نوشته شده بود به 100 درصد تصحیح شد.
به علت کم بودن بیماران واجد شرایط و عدم بیمارگیری طرح چند مرکزی شد و مطالعه در بخش ICU استروک بیمارستان فیروزگر، بخش مراقبت های ویژه بیمارستان شهدای تجریش دانشگاه علوم پزشکی شهید بهشتی، بخش مراقبت های ویژه بیمارستان سینا دانشگاه علوم پزشکی تهران, بخش مراقبت های ویژه بیمارستان رسول اکرم انجام خواهد شد. طول مدت مداخله با توجه به مطالعات به 28 روز کاهش یافت. حجم نمونه پیش بینی شده به 60 نفر تغییر یافت. فرد مسوول در بیمارستان فیروزگر تغییر یافت. درصد حمایت مالی به اشتباه 26 درصد نوشته شده بود به 100 درصد تصحیح شد.
Willingness to cooperate and complete the informed consent form by the patient or legal guardian, patients aged 18-85 years, body mass index ≤ 35 kg/m2, starting the intervention within 24 hours after being admitted to the ICU and not spending More than 24 hours from the time of disease diagnosis until the time of entering the study, the severity of stroke based on the NIHSS standard is higher than 4, the patient's GCS at the time of visit is higher than 3, feeding by enteral feeding method, receiving at least 80 percent of the prescribed formula during the first 48 hours, none Absolute contraindications for enteral feeding (permanent ileus, ischemia of the digestive tract, bilious or continuous vomiting and mechanical obstruction), the possibility of hospitalization in the intensive care unit (ICU) for 30 days, not suffering from hepatic encephalopathy and liver cirrhosis, not suffering from metastatic cancer, not having infection and sepsis, not having AIDS (HIV), not having hepatitis, not receiving supplements or formulas that strengthen the immune system, including arginine, glutamine, colostrum, vitamins C and E, selenium, zinc or Omega-3 fatty acids or resveratrol supplement during the last 30 days before the start of the intervention, not suffering from allergies or intolerance to the enteral formula used in the present study and resveratrol supplement, non-participation in other interventional studies. No company in the past 30 days in other clinical trial studies at the same time as the present study
Willingness to cooperate and complete the informed consent form by the patient or legal guardian, patients aged 18-85 years, body mass index ≤ 35 kg/m2, starting the intervention within 24 hours after being admitted to the ICU and not spending More than 24 hours from the time of disease diagnosis until the time of entering the study, the severity of stroke based on the NIHSS standard is higher than 4, the patient's GCS at the time of visit is higher than 3, feeding by enteral feeding method, receiving at least 80 percent of the prescribed formula during the first 48 hours, none Absolute contraindications for enteral feeding (permanent ileus, ischemia of the digestive tract, bilious or continuous vomiting and mechanical obstruction), the possibility of hospitalization in the intensive care unit (ICU) for 28 days, not suffering from hepatic encephalopathy and liver cirrhosis, not suffering from metastatic cancer, not having infection and sepsis, not having AIDS (HIV), not having hepatitis, not receiving supplements or formulas that strengthen the immune system, including arginine, glutamine, colostrum, vitamins C and E, selenium, zinc or Omega-3 fatty acids or resveratrol supplement during the last 30 days before the start of the intervention, not suffering from allergies or intolerance to the enteral formula used in the present study and resveratrol supplement, non-participation in other interventional studies. No company in the past 30 days in other clinical trial studies at the same time as the present study
Willingness to cooperate and complete the informed consent form by the patient or legal guardian, patients aged 18-85 years, body mass index ≤ 35 kg/m2, starting the intervention within 24 hours after being admitted to the ICU and not spending More than 24 hours from the time of disease diagnosis until the time of entering the study, the severity of stroke based on the NIHSS standard is higher than 4, the patient's GCS at the time of visit is higher than 3, feeding by enteral feeding method, receiving at least 80 percent of the prescribed formula during the first 48 hours, none Absolute contraindications for enteral feeding (permanent ileus, ischemia of the digestive tract, bilious or continuous vomiting and mechanical obstruction), the possibility of hospitalization in the intensive care unit (ICU) for 3028 days, not suffering from hepatic encephalopathy and liver cirrhosis, not suffering from metastatic cancer, not having infection and sepsis, not having AIDS (HIV), not having hepatitis, not receiving supplements or formulas that strengthen the immune system, including arginine, glutamine, colostrum, vitamins C and E, selenium, zinc or Omega-3 fatty acids or resveratrol supplement during the last 30 days before the start of the intervention, not suffering from allergies or intolerance to the enteral formula used in the present study and resveratrol supplement, non-participation in other interventional studies. No company in the past 30 days in other clinical trial studies at the same time as the present study
تماﯾﻞ ﺑﻪ ﻫﻤﮑﺎري و ﺗﮑﻤﯿﻞ ﻓﺮم رﺿﺎﯾﺖ ﻧﺎﻣﻪ آﮔﺎﻫﺎﻧﻪ ﺗﻮﺳﻂ ﺑﯿﻤﺎر ﯾﺎ وﻟﯽ ﻗﺎﻧﻮﻧﯽ، ﺑﯿﻤﺎران 18-85 سال، ﻧﻤﺎﯾﻪ ﺗﻮده ﺑﺪن 35 ≥ ﮐﯿﻠﻮﮔﺮم ﺑﺮ ﻣﺘﺮ ﻣﺮﺑﻊ، ﺷﺮوع ﻣﺪاﺧﻠﻪ در ﻃﻮل 24 ﺳﺎﻋﺖ ﭘﺲ از ﭘﺬﯾﺮش در ICU و ﻋﺪم ﺳﭙﺮي ﺷﺪن ﺑﯿﺶ از24 ﺳﺎﻋﺖ از زﻣﺎن ﺗﺸﺨﯿﺺ ﺑﯿﻤﺎري ﺗﺎ زﻣﺎن ورود ﺑﻪ ﻣﻄﺎﻟﻌﻪ، شدت سکته مغزی بر اساس معيار NIHSS بالاتر از 4، GCS بیمار در بدو مراجعه بیشتر از 3 ، تغذیه ﺑﻪ روش ﺗﻐﺬﯾﻪ اﻧﺘﺮال، دریافت ﺣﺪاﻗﻞ 80 درﺻﺪ از ﻓﺮﻣﻮﻻي ﺗﺠﻮﯾﺰي در ﻃﻮل 48 ﺳﺎﻋﺖ اول، ﻋﺪم وﺟﻮد ﮐﻨﺘﺮا اﻧﺪﯾﮑﺎﺳﯿﻮن ﻫﺎي ﻣﻄﻠﻖ ﺗﻐﺬﯾﻪ اﻧﺘﺮال (اﯾﻠﺌﻮس ﭘﺎﯾﺪار، اﯾﺴﮑﻤﯽ دﺳﺘﮕﺎه ﮔﻮارش، اﺳﺘﻔﺮاغ ﺻﻔﺮاوي یا مداوم و انسداد مکانیکی)، احتمال ﺑﺴﺘﺮي در ﺑﺨﺶ ﻣﺮاﻗﺒﺖ ﻫﺎي وﯾﮋه (ICU) 30 روز، ﻋﺪم اﺑﺘﻼ ﺑﻪ آﻧﺴﻔﺎﻟﻮﭘﺎﺗﯽ ﮐﺒﺪي و ﺳﯿﺮوز ﮐﺒﺪي، ﻋﺪم اﺑﺘﻼ ﺑﻪ ﺳﺮﻃﺎن ﻣﺘﺎﺳﺘﺎﺗﯿﮏ، عدم اﺑﺘﻼ ﺑﻪ ﻋﻔﻮﻧﺖ و ﺳﭙﺴﯿﺲ، عدم ابتلا به ایدز (HIV)، عدم ابتلا به هپاتیت، ﻋﺪم درﯾﺎﻓﺖ ﻣﮑﻤﻞ ﻫﺎ ﯾﺎ ﻓﺮﻣﻮﻻﻫﺎي ﺗﻘﻮﯾﺖ ﮐﻨﻨﺪه ﺳﯿﺴﺘﻢ اﯾﻤﻨﯽ ﺷﺎﻣﻞ: آرژﻧﯿﻦ، ﮔﻠﻮﺗﺎﻣﯿﻦ، ﮐﻠﺴﺘﺮوم، وﯾﺘﺎﻣﯿﻦ ﻫﺎي C و E، ﺳﻠﻨﯿﻮم، روي و ﯾﺎ اﺳﯿﺪﻫﺎي ﭼﺮب اﻣﮕﺎ-3 یا مکمل رزوراترول در ﻃﻮل 30 روز اﺧﯿﺮ ﻗﺒﻞ از ﺷﺮوع ﻣﺪاﺧﻠﻪ، ﻋﺪم اﺑﺘﻼ ﺑﻪ آﻟﺮژي و ﯾﺎ ﻋﺪم ﺗﺤﻤﻞ ﺑﻪ ﻓﺮﻣﻮﻻي اﻧﺘﺮال ﻣﻮرد اﺳﺘﻔﺎده در ﭘﮋوﻫﺶ ﺣﺎﺿﺮ و ﻣﮑﻤﻞ رزوراترول، عدم ﺷﺮﮐﺖ در ﺳﺎﯾﺮ ﻣﻄﺎﻟﻌﺎت ﺗﺪاﺧﻠﯽ در30 روز ﮔﺬﺷﺘﻪ، ﻋﺪم ﺷﺮﮐﺖ در ﺳﺎﯾﺮ ﻣﻄﺎﻟﻌﺎت ﮐﺎرآزﻣﺎﯾﯽ ﺑﺎﻟﯿﻨﯽ ﻫﻤﺰﻣﺎن ﺑﺎ ﻣﻄﺎﻟﻌﻪ ﺣﺎﺿﺮ
تماﯾﻞ ﺑﻪ ﻫﻤﮑﺎري و ﺗﮑﻤﯿﻞ ﻓﺮم رﺿﺎﯾﺖ ﻧﺎﻣﻪ آﮔﺎﻫﺎﻧﻪ ﺗﻮﺳﻂ ﺑﯿﻤﺎر ﯾﺎ وﻟﯽ ﻗﺎﻧﻮﻧﯽ، ﺑﯿﻤﺎران 18-85 سال، ﻧﻤﺎﯾﻪ ﺗﻮده ﺑﺪن 35 ≥ ﮐﯿﻠﻮﮔﺮم ﺑﺮ ﻣﺘﺮ ﻣﺮﺑﻊ، ﺷﺮوع ﻣﺪاﺧﻠﻪ در ﻃﻮل 24 ﺳﺎﻋﺖ ﭘﺲ از ﭘﺬﯾﺮش در ICU و ﻋﺪم ﺳﭙﺮي ﺷﺪن ﺑﯿﺶ از24 ﺳﺎﻋﺖ از زﻣﺎن ﺗﺸﺨﯿﺺ ﺑﯿﻤﺎري ﺗﺎ زﻣﺎن ورود ﺑﻪ ﻣﻄﺎﻟﻌﻪ، شدت سکته مغزی بر اساس معيار NIHSS بالاتر از 4، GCS بیمار در بدو مراجعه بیشتر از 3 ، تغذیه ﺑﻪ روش ﺗﻐﺬﯾﻪ اﻧﺘﺮال، دریافت ﺣﺪاﻗﻞ 80 درﺻﺪ از ﻓﺮﻣﻮﻻي ﺗﺠﻮﯾﺰي در ﻃﻮل 48 ﺳﺎﻋﺖ اول، ﻋﺪم وﺟﻮد ﮐﻨﺘﺮا اﻧﺪﯾﮑﺎﺳﯿﻮن ﻫﺎي ﻣﻄﻠﻖ ﺗﻐﺬﯾﻪ اﻧﺘﺮال (اﯾﻠﺌﻮس ﭘﺎﯾﺪار، اﯾﺴﮑﻤﯽ دﺳﺘﮕﺎه ﮔﻮارش، اﺳﺘﻔﺮاغ ﺻﻔﺮاوي یا مداوم و انسداد مکانیکی)، احتمال ﺑﺴﺘﺮي در ﺑﺨﺶ ﻣﺮاﻗﺒﺖ ﻫﺎي وﯾﮋه (ICU) 28 روز، ﻋﺪم اﺑﺘﻼ ﺑﻪ آﻧﺴﻔﺎﻟﻮﭘﺎﺗﯽ ﮐﺒﺪي و ﺳﯿﺮوز ﮐﺒﺪي، ﻋﺪم اﺑﺘﻼ ﺑﻪ ﺳﺮﻃﺎن ﻣﺘﺎﺳﺘﺎﺗﯿﮏ، عدم اﺑﺘﻼ ﺑﻪ ﻋﻔﻮﻧﺖ و ﺳﭙﺴﯿﺲ، عدم ابتلا به ایدز (HIV)، عدم ابتلا به هپاتیت، ﻋﺪم درﯾﺎﻓﺖ ﻣﮑﻤﻞ ﻫﺎ ﯾﺎ ﻓﺮﻣﻮﻻﻫﺎي ﺗﻘﻮﯾﺖ ﮐﻨﻨﺪه ﺳﯿﺴﺘﻢ اﯾﻤﻨﯽ ﺷﺎﻣﻞ: آرژﻧﯿﻦ، ﮔﻠﻮﺗﺎﻣﯿﻦ، ﮐﻠﺴﺘﺮوم، وﯾﺘﺎﻣﯿﻦ ﻫﺎي C و E، ﺳﻠﻨﯿﻮم، روي و ﯾﺎ اﺳﯿﺪﻫﺎي ﭼﺮب اﻣﮕﺎ-3 یا مکمل رزوراترول در ﻃﻮل 30 روز اﺧﯿﺮ ﻗﺒﻞ از ﺷﺮوع ﻣﺪاﺧﻠﻪ، ﻋﺪم اﺑﺘﻼ ﺑﻪ آﻟﺮژي و ﯾﺎ ﻋﺪم ﺗﺤﻤﻞ ﺑﻪ ﻓﺮﻣﻮﻻي اﻧﺘﺮال ﻣﻮرد اﺳﺘﻔﺎده در ﭘﮋوﻫﺶ ﺣﺎﺿﺮ و ﻣﮑﻤﻞ رزوراترول، عدم ﺷﺮﮐﺖ در ﺳﺎﯾﺮ ﻣﻄﺎﻟﻌﺎت ﺗﺪاﺧﻠﯽ در 30 روز ﮔﺬﺷﺘﻪ، ﻋﺪم ﺷﺮﮐﺖ در ﺳﺎﯾﺮ ﻣﻄﺎﻟﻌﺎت ﮐﺎرآزﻣﺎﯾﯽ ﺑﺎﻟﯿﻨﯽ ﻫﻤﺰﻣﺎن ﺑﺎ ﻣﻄﺎﻟﻌﻪ ﺣﺎﺿﺮ
تماﯾﻞ ﺑﻪ ﻫﻤﮑﺎري و ﺗﮑﻤﯿﻞ ﻓﺮم رﺿﺎﯾﺖ ﻧﺎﻣﻪ آﮔﺎﻫﺎﻧﻪ ﺗﻮﺳﻂ ﺑﯿﻤﺎر ﯾﺎ وﻟﯽ ﻗﺎﻧﻮﻧﯽ، ﺑﯿﻤﺎران 18-85 سال، ﻧﻤﺎﯾﻪ ﺗﻮده ﺑﺪن 35 ≥ ﮐﯿﻠﻮﮔﺮم ﺑﺮ ﻣﺘﺮ ﻣﺮﺑﻊ، ﺷﺮوع ﻣﺪاﺧﻠﻪ در ﻃﻮل 24 ﺳﺎﻋﺖ ﭘﺲ از ﭘﺬﯾﺮش در ICU و ﻋﺪم ﺳﭙﺮي ﺷﺪن ﺑﯿﺶ از24 ﺳﺎﻋﺖ از زﻣﺎن ﺗﺸﺨﯿﺺ ﺑﯿﻤﺎري ﺗﺎ زﻣﺎن ورود ﺑﻪ ﻣﻄﺎﻟﻌﻪ، شدت سکته مغزی بر اساس معيار NIHSS بالاتر از 4، GCS بیمار در بدو مراجعه بیشتر از 3 ، تغذیه ﺑﻪ روش ﺗﻐﺬﯾﻪ اﻧﺘﺮال، دریافت ﺣﺪاﻗﻞ 80 درﺻﺪ از ﻓﺮﻣﻮﻻي ﺗﺠﻮﯾﺰي در ﻃﻮل 48 ﺳﺎﻋﺖ اول، ﻋﺪم وﺟﻮد ﮐﻨﺘﺮا اﻧﺪﯾﮑﺎﺳﯿﻮن ﻫﺎي ﻣﻄﻠﻖ ﺗﻐﺬﯾﻪ اﻧﺘﺮال (اﯾﻠﺌﻮس ﭘﺎﯾﺪار، اﯾﺴﮑﻤﯽ دﺳﺘﮕﺎه ﮔﻮارش، اﺳﺘﻔﺮاغ ﺻﻔﺮاوي یا مداوم و انسداد مکانیکی)، احتمال ﺑﺴﺘﺮي در ﺑﺨﺶ ﻣﺮاﻗﺒﺖ ﻫﺎي وﯾﮋه (ICU) 3028 روز، ﻋﺪم اﺑﺘﻼ ﺑﻪ آﻧﺴﻔﺎﻟﻮﭘﺎﺗﯽ ﮐﺒﺪي و ﺳﯿﺮوز ﮐﺒﺪي، ﻋﺪم اﺑﺘﻼ ﺑﻪ ﺳﺮﻃﺎن ﻣﺘﺎﺳﺘﺎﺗﯿﮏ، عدم اﺑﺘﻼ ﺑﻪ ﻋﻔﻮﻧﺖ و ﺳﭙﺴﯿﺲ، عدم ابتلا به ایدز (HIV)، عدم ابتلا به هپاتیت، ﻋﺪم درﯾﺎﻓﺖ ﻣﮑﻤﻞ ﻫﺎ ﯾﺎ ﻓﺮﻣﻮﻻﻫﺎي ﺗﻘﻮﯾﺖ ﮐﻨﻨﺪه ﺳﯿﺴﺘﻢ اﯾﻤﻨﯽ ﺷﺎﻣﻞ: آرژﻧﯿﻦ، ﮔﻠﻮﺗﺎﻣﯿﻦ، ﮐﻠﺴﺘﺮوم، وﯾﺘﺎﻣﯿﻦ ﻫﺎي C و E، ﺳﻠﻨﯿﻮم، روي و ﯾﺎ اﺳﯿﺪﻫﺎي ﭼﺮب اﻣﮕﺎ-3 یا مکمل رزوراترول در ﻃﻮل 30 روز اﺧﯿﺮ ﻗﺒﻞ از ﺷﺮوع ﻣﺪاﺧﻠﻪ، ﻋﺪم اﺑﺘﻼ ﺑﻪ آﻟﺮژي و ﯾﺎ ﻋﺪم ﺗﺤﻤﻞ ﺑﻪ ﻓﺮﻣﻮﻻي اﻧﺘﺮال ﻣﻮرد اﺳﺘﻔﺎده در ﭘﮋوﻫﺶ ﺣﺎﺿﺮ و ﻣﮑﻤﻞ رزوراترول، عدم ﺷﺮﮐﺖ در ﺳﺎﯾﺮ ﻣﻄﺎﻟﻌﺎت ﺗﺪاﺧﻠﯽ در30در 30 روز ﮔﺬﺷﺘﻪ، ﻋﺪم ﺷﺮﮐﺖ در ﺳﺎﯾﺮ ﻣﻄﺎﻟﻌﺎت ﮐﺎرآزﻣﺎﯾﯽ ﺑﺎﻟﯿﻨﯽ ﻫﻤﺰﻣﺎن ﺑﺎ ﻣﻄﺎﻟﻌﻪ ﺣﺎﺿﺮ
Ethics committees
#1
2023-07-01, 1402/04/10
2024-12-22, 1403/10/02
20232024-0712-0122 00:00:00
Primary outcomes
#1
At the beginning of the study and 30th day
At the beginning of the study and 28th day
At the beginning of the study and 30th28th day
در ابتدای مطالعه و روز سی ام
در ابتدای مطالعه و روز بیست و هشتم
در ابتدای مطالعه و روز سی امبیست و هشتم
#2
At the beginning of the study and 30th day
At the beginning of the study and 28th day
At the beginning of the study and 30th28th day
در ابتدای مطالعه و روز سی ام
در ابتدای مطالعه و روز بیست و هشتم
در ابتدای مطالعه و روز سی امبیست و هشتم
Secondary outcomes
#1
At the beginning of the study and 30th day
At the beginning of the study and 28th day
At the beginning of the study and 30th28th day
در ابتدای مطالعه و بعد از سی روز مداخله
در ابتدای مطالعه و بعد از بیست و هشت روز مداخله
در ابتدای مطالعه و بعد از سیبیست و هشت روز مداخله
#2
At the beginning of the study and 30th day
At the beginning of the study and 28th day
At the beginning of the study and 30th28th day
در ابتدای مطالعه و بعد از سی روز مداخله
در ابتدای مطالعه و بعد از بیست و هشت روز مداخله
در ابتدای مطالعه و بعد از سیبیست و هشت روز مداخله
#3
At the beginning of the study and after thirty days of intervention
At the beginning of the study and after twenty-eight days of intervention
At the beginning of the study and after thirtytwenty-eight days of intervention
در ابتدای مطالعه و بعد از سی روز مداخله
در ابتدای مطالعه و بعد از بیست و هشت روز مداخله
در ابتدای مطالعه و بعد از سیبیست و هشت روز مداخله
#4
At the beginning of the study and after thirty days of intervention
At the beginning of the study and after twenty-eight days of intervention
At the beginning of the study and after thirtytwenty-eight days of intervention
در ابتدای مطالعه و بعد از سی روز مداخله
در ابتدای مطالعه و بعد از بیست و هشت روز مداخله
در ابتدای مطالعه و بعد از سیبیست و هشت روز مداخله
#5
At the beginning of the study and after thirty days of intervention
At the beginning of the study and after twenty-eight days of intervention
At the beginning of the study and after thirtytwenty-eight days of intervention
در ابتدای مطالعه و بعد از سی روز مداخله
در ابتدای مطالعه و بعد از بیست و هشت روز مداخله
در ابتدای مطالعه و بعد از سیبیست و هشت روز مداخله
#6
At the beginning of the study and after thirty days of intervention
At the beginning of the study and after twenty-eight days of intervention
At the beginning of the study and after thirtytwenty-eight days of intervention
در ابتدای مطالعه و بعد از سی روز مداخله
در ابتدای مطالعه و بعد از بیست و هشت روز مداخله
در ابتدای مطالعه و بعد از سیبیست و هشت روز مداخله
#7
At the beginning of the study and after thirty days of intervention
At the beginning of the study and after twenty-eight days of intervention
At the beginning of the study and after thirtytwenty-eight days of intervention
در ابتدای مطالعه و بعد از سی روز مداخله
در ابتدای مطالعه و بعد از بیست و هشت روز مداخله
در ابتدای مطالعه و بعد از سیبیست و هشت روز مداخله
#8
At the beginning of the study and after thirty days of intervention
At the beginning of the study and after twenty-eight days of intervention
At the beginning of the study and after thirtytwenty-eight days of intervention
در ابتدای مطالعه و بعد از سی روز مداخله
در ابتدای مطالعه و بعد از بیست و هشت روز مداخله
در ابتدای مطالعه و بعد از سیبیست و هشت روز مداخله
#9
At the beginning of the study and after thirty days of intervention
At the beginning of the study and after twenty-eight days of intervention
At the beginning of the study and after thirtytwenty-eight days of intervention
در ابتدای مطالعه و بعد از سی روز مداخله
در ابتدای مطالعه و بعد از بیست و هشت روز مداخله
در ابتدای مطالعه و بعد از سیبیست و هشت روز مداخله
#10
At the beginning of the study and after thirty days of intervention
At the beginning of the study and after twenty-eight days of intervention
At the beginning of the study and after thirtytwenty-eight days of intervention
در ابتدای مطالعه و بعد از سی روز مداخله
در ابتدای مطالعه و بعد از بیست و هشت روز مداخله
در ابتدای مطالعه و بعد از سیبیست و هشت روز مداخله
#11
At the beginning of the study and after thirty days of intervention
At the beginning of the study and after twenty-eight days of intervention
At the beginning of the study and after thirtytwenty-eight days of intervention
در ابتدای مطالعه و بعد از سی روز مداخله
در ابتدای مطالعه و بعد از بیست و هشت روز مداخله
در ابتدای مطالعه و بعد از سیبیست و هشت روز مداخله
Intervention groups
#1
Control group: Daily intake of placebo for 30 days
Control group: Daily intake of placebo for 28 days
Control group: Daily intake of placebo for 3028 days
گروه کنترل: دریافت روزانه دارونما به مدت 30 روز
گروه کنترل: دریافت روزانه دارونما به مدت 28 روز
گروه کنترل: دریافت روزانه دارونما به مدت 3028 روز
Recruitment centers
#1
Name of recruitment center - English: Firouzgar educational, research and treatment center
Name of recruitment center - Persian: مرکز آموزشی، پژوهشی و درمانی فیروزگر
Full name of responsible person - English: Bahram Haghi Ashtiani
Full name of responsible person - Persian: بهرام حقی آشتیانی
Street address - English: Beh Afarin St., Karim Khan Zand Blvd., Tehran, Iran
Street address - Persian: خيابان به آفرين، ميدان وليعصر (عج)، تهران، ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1593747811
Phone: +98 21 8214 1000
Fax:
Email: bhaghi2000@yahoo.com
Web page address:
Name of recruitment center - English: Firouzgar educational, research and treatment, center
Name of recruitment center - Persian: مرکز آموزشی، پژوهشی و درمانی فیروزگر
Full name of responsible person - English: Tara Khoeini
Full name of responsible person - Persian: تارا خوینی
Street address - English: Beh Afarin St., Karim Khan Zand Blvd., Tehran, Iran
Street address - Persian: خيابان به آفرين، ميدان وليعصر (عج)، تهران، ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1593747811
Phone: +98 21 8214 1000
Fax:
Email: h_firoozgar@yahoo.com
Web page address:
Name of recruitment center - English: Firouzgar educational, research and treatment, center Name of recruitment center - Persian: مرکز آموزشی، پژوهشی و درمانی فیروزگر Full name of responsible person - English: Bahram Haghi AshtianiTara Khoeini Full name of responsible person - Persian: بهرام حقی آشتیانیتارا خوینی Street address - English: Beh Afarin St., Karim Khan Zand Blvd., Tehran, Iran Street address - Persian: خيابان به آفرين، ميدان وليعصر (عج)، تهران، ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1593747811 Phone: +98 21 8214 1000 Fax: Email: bhaghi2000h_firoozgar@yahoo.com Web page address:
#2
Name of recruitment center - English: Shohadaye Tajrish Hospital
Name of recruitment center - Persian: مرکز پزشکی، آموزشی و درمانی شهدای تجریش
Full name of responsible person - English: سید حسین اردهالی
Full name of responsible person - Persian: Seyed Hosein Ardehali
Street address - English: Shahrdari Street,Tajrish Sqr
Street address - Persian: میدان تجریش، خیابان شهرداری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1989934148
Phone: +98 21 2271 8000
Fax:
Email: pr-shohada@sbmu.ac.ir
Web page address:
Name of recruitment center - English: Shohadaye Tajrish Hospital Name of recruitment center - Persian: مرکز پزشکی، آموزشی و درمانی شهدای تجریش Full name of responsible person - English: سید حسین اردهالی Full name of responsible person - Persian: Seyed Hosein Ardehali Street address - English: Shahrdari Street,Tajrish Sqr Street address - Persian: میدان تجریش، خیابان شهرداری City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1989934148 Phone: +98 21 2271 8000 Fax: Email: pr-shohada@sbmu.ac.ir Web page address:
#3
Name of recruitment center - English: Sina Hospital
Name of recruitment center - Persian: بیمارستان سینا
Full name of responsible person - English: Gelareh Banihashemi
Full name of responsible person - Persian: گلاره بنی هاشمی
Street address - English: Hassan-Abad Square, Imam-Khomeini Ave
Street address - Persian: خیابان امام خمینی- نرسیده به میدان حسن آباد
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1136746911
Phone: +98 21 6634 8500
Fax:
Email: hosp_sina@sina.tums.ac.ir
Web page address:
Name of recruitment center - English: Sina Hospital Name of recruitment center - Persian: بیمارستان سینا Full name of responsible person - English: Gelareh Banihashemi Full name of responsible person - Persian: گلاره بنی هاشمی Street address - English: Hassan-Abad Square, Imam-Khomeini Ave Street address - Persian: خیابان امام خمینی- نرسیده به میدان حسن آباد City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1136746911 Phone: +98 21 6634 8500 Fax: Email: hosp_sina@sina.tums.ac.ir Web page address:
#4
Name of recruitment center - English: Hazrat Rasul Akram educational, research and treatment complex
Name of recruitment center - Persian: مرکز آموزشی پژوهشی درمانی حضرت رسول اکرم (ص)
Full name of responsible person - English: Omid Moradimoghadam
Full name of responsible person - Persian: امید مرادی مقدم
Street address - English: Starkhan-Niyaish Street-Corner of Mansouri Street
Street address - Persian: ستارخان-خیابان نیایش-نبش خیابان منصوری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6435 1000
Fax:
Email: rasoolhospital@iums.ac.ir
Web page address:
Name of recruitment center - English: Hazrat Rasul Akram educational, research and treatment complex Name of recruitment center - Persian: مرکز آموزشی پژوهشی درمانی حضرت رسول اکرم (ص) Full name of responsible person - English: Omid Moradimoghadam Full name of responsible person - Persian: امید مرادی مقدم Street address - English: Starkhan-Niyaish Street-Corner of Mansouri Street Street address - Persian: ستارخان-خیابان نیایش-نبش خیابان منصوری City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1445613131 Phone: +98 21 6435 1000 Fax: Email: rasoolhospital@iums.ac.ir Web page address:
Sponsors / Funding sources
#1
26
100
26100
Protocol summary
Study aim
Determining the effect of resveratrol supplementation on the expression of some genes mediating immunity and inflammation, inflammatory factors, oxidative stress, and clinical outcomes in patients with acute ischemic stroke receiving enteral nutrition hospitalized in the intensive care unit
Design
A controlled, parallel-group, triple-blind, randomized, phase 3 clinical trial on 60 patients with acute ischemic stroke, randomized blocks
Settings and conduct
The study will take place at the Firouzgar Hospital. Patients will be randomly assigned to two groups: Resveratrol (containing 250 mg of resveratrol and 10 mg of grape skin extract) TDS (30 people); and placebo (containing maltodextrin, similar to resveratrol capsules)TDS (30 people) for 28 days. Stroke severity will be measured using the NIHSS Stroke Scale. At the beginning and end of the study, 10 cc of IV blood samples will be collected from participants. Mononuclear cells will be extracted from these samples to perform quantitative real-time PCR, and RNA will be extracted and converted into cDNA using a kit. Serum levels of IL-1β and IL-6 will be evaluated using a kit and ELISA method. The serum total antioxidant capacity and serum malondialdehyde level will be evaluated using a kit and calorimetric method. The researcher, the neurologist, individuals involved in blood collection and sample evaluation, and the person performing statistical analysis will all be blinded.
Participants/Inclusion and exclusion criteria
Patients with acute ischemic stroke receiving enteral nutrition admitted to the intensive care unit
Intervention groups
Resveratrol capsules containing 250 mg of resveratrol and 10 mg of grape skin extract three times a day, equivalent to 750 mg of resveratrol and 30 mg of grape skin extract, placebo capsule (containing maltodextrin)
Due to the low number of eligible patients and lack of patient recruitment, the design will be multicentered. The study will be conducted in the Stroke ICU of Firoozgar Hospital, the Intensive Care Unit of Shohadaye Tajrish Hospital of Shahid Beheshti University of Medical Sciences, the Intensive Care Unit of Sina Hospital of Tehran University of Medical Sciences, and the Intensive Care Unit of Rasoul Akram Hospital. According to the studies, we reduce the duration of the intervention to 28 days. The sample size, with the calculation of 20% drop out of the study, will be 60 patients. The responsible person in Firouzgar Hospital changed. The percentage of financial support was incorrectly written as 26%, but it was corrected to 100%.
Acronym
IRCT registration information
IRCT registration number:IRCT20091114002709N61
Registration date:2023-07-24, 1402/05/02
Registration timing:prospective
Last update:2024-12-27, 1403/10/07
Update count:1
Registration date
2023-07-24, 1402/05/02
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-30, 1403/10/10
Expected recruitment end date
2025-12-31, 1404/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of resveratrol supplement on some mediator genes of immunity and inflammation, inflammatory factors, oxidative stress and clinical outcomes in hospitalized acute ischemic stroke patients with enteral feeding in intensive care unit: A randomized triple-blind placebo-controlled trial
Public title
Resveratrol in acute ischemic stroke
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to cooperate and complete the informed consent form by the patient or legal guardian, patients aged 18-85 years, body mass index ≤ 35 kg/m2, starting the intervention within 24 hours after being admitted to the ICU and not spending More than 24 hours from the time of disease diagnosis until the time of entering the study, the severity of stroke based on the NIHSS standard is higher than 4, the patient's GCS at the time of visit is higher than 3, feeding by enteral feeding method, receiving at least 80 percent of the prescribed formula during the first 48 hours, none Absolute contraindications for enteral feeding (permanent ileus, ischemia of the digestive tract, bilious or continuous vomiting and mechanical obstruction), the possibility of hospitalization in the intensive care unit (ICU) for 28 days, not suffering from hepatic encephalopathy and liver cirrhosis, not suffering from metastatic cancer, not having infection and sepsis, not having AIDS (HIV), not having hepatitis, not receiving supplements or formulas that strengthen the immune system, including arginine, glutamine, colostrum, vitamins C and E, selenium, zinc or Omega-3 fatty acids or resveratrol supplement during the last 30 days before the start of the intervention, not suffering from allergies or intolerance to the enteral formula used in the present study and resveratrol supplement, non-participation in other interventional studies. No company in the past 30 days in other clinical trial studies at the same time as the present study
Exclusion criteria:
Pregnancy, lactation, intracranial hemorrhage, history of previous stroke, consumption of any natural food containing resveratrol within 48 hours before the onset of stroke, patients who received rtPA, more than 24 hours from onset of symptoms, seizure at onset Stroke, intracranial hemorrhage, symptoms suggestive of subarachnoid hemorrhage, rapid recovery or partial symptoms, stroke severity based on NIHSS criteria less than 4, patient suffering from dementia before stroke
Age
From 18 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
If they meet the criteria for entering the study, they will be placed in one of the two study groups based on age (18-65 and ≥65) and gender. Randomization will be done using the Block Randomization technique using the Sealed Envelope online site. The random code of this study will be generated electronically using the block of four technique online site.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Resveratrol will be purchased from Raha company, its purity is 100% and its type is trans, and the placebo will be made by the Faculty of Pharmacy of Iran University of Medical Sciences. Drug treatment will be similar in both groups. Random codes will be placed in sealed envelopes. All researchers, participants, and laboratory technicians will be blinded to the patient allocation process and intervention content. All the data is coded by another person who does not intervene in the study at first, and the person who analyzes the obtained data does not know about the process of allocating patients until the end, and thus the study will be three-way blind. Supplements and placebo are placed in similar containers. They will be coded as groups A and B by a person other than the researcher outside the study so that the researcher is unaware of the contents of the capsules, and in this way, the researcher is not aware of the drug and placebo. Blinding is done so that the lack of knowledge of the type of supplements each group receives is considered.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Iran University of Medical Sciences
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
14496-14535
Approval date
2024-12-22, 1403/10/02
Ethics committee reference number
IR.IUMS.REC.1402.293
Health conditions studied
1
Description of health condition studied
Acute ischemic stroke
ICD-10 code
I63.9
ICD-10 code description
Cerebral infarction, unspecified
Primary outcomes
1
Description
IL-1β gene expression
Timepoint
At the beginning of the study and 28th day
Method of measurement
Real-time PCR
2
Description
Stroke severity score NIHSS: National Institutes of Health Stroke Scale
Timepoint
At the beginning of the study and 28th day
Method of measurement
Physical examination
Secondary outcomes
1
Description
NLRP3 gene expression
Timepoint
At the beginning of the study and 28th day
Method of measurement
Real-time PCR
2
Description
ASC gene expression
Timepoint
At the beginning of the study and 28th day
Method of measurement
Real-time PCR
3
Description
Caspase-1gene expression
Timepoint
At the beginning of the study and after twenty-eight days of intervention
Method of measurement
Real-time PCR
4
Description
Serum levels of IL-1β
Timepoint
At the beginning of the study and after twenty-eight days of intervention
Method of measurement
By ELISA kit
5
Description
Serum levels of IL-6
Timepoint
At the beginning of the study and after twenty-eight days of intervention
Method of measurement
By ELISA kit
6
Description
Serum total antioxidant capacity
Timepoint
At the beginning of the study and after twenty-eight days of intervention
Method of measurement
Colorimetric
7
Description
Serm malondialdehyde (MDA) level
Timepoint
At the beginning of the study and after twenty-eight days of intervention
Method of measurement
Colorimetric
8
Description
Barthel Index
Timepoint
28 days after the end of the intervention and 90 days after the end of the intervention
Method of measurement
Based on specific forms that the patient or his / her companions will be asked by phone or in person.
9
Description
Modified Rankin Scale (MRS)
Timepoint
28 days after the end of the intervention and 90 days after the end of the intervention
Method of measurement
Based on specific forms that the patient or his / her companions will be asked by phone or in person.
10
Description
APACHE II score
Timepoint
At the beginning of the study and after twenty-eight days of intervention
Method of measurement
in this study, APACHEII questionnaire will be complimented.
11
Description
SOFA score
Timepoint
At the beginning of the study and after twenty-eight days of intervention
Method of measurement
in this study, SOFA questionnaire will be complimented.
12
Description
NUTRIC score
Timepoint
At the beginning of the study and after twenty-eight days of intervention
Method of measurement
in this study, NUTRIC score questionnaire will be complimented.
13
Description
Mini-Mental State Examination (MMSE)
Timepoint
90 days after the end of the intervention
Method of measurement
in this study, MMSE score questionnaire will be complimented.
14
Description
Anthropometric indices
Timepoint
At the beginning of the study and after twenty-eight days of intervention
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group: Resveratrol capsules containing 250 mg of resveratrol and 10 mg of grape skin extract three times a day, equivalent to 750 mg of resveratrol and 30 mg of grape skin extract
Category
Treatment - Other
2
Description
Control group: Daily intake of placebo for 28 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Firouzgar educational, research and treatment, center