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IRCT20091114002709N61 IRCT 2023-07-24 Iran University of Medical Sciences Resveratrol in acute ischemic stroke 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 2024-12-30 anticipated 60 Complete https://irct.ir/trial/71123 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, 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 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. 3 Acute ischemic stroke. Intervention 1: 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. Intervention 2: Control group: Daily intake of placebo for 28 days. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Only for researchers working in academic and scientific institutions Conditions: In order to use the data to conduct another study or use in patients Where to obtain: Dr Farzad Shidfar, shidfar.f@iums.ac.ir How to obtain: Request by e-mail along with providing a complete explanation of why the data is needed Comments:
public Farzad shidfar
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8860 2218 farzadshidfar@yahoo.com Iran University of Medical Sciences scientific Farzad shidfar
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4743 farzadshidfar@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years 85 years Both 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 I63.9 Cerebral infarction, unspecified Treatment - Other Placebo 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 Control group: Daily intake of placebo for 28 days IL-1β gene expression. Timepoint: At the beginning of the study and 28th day. Method of measurement: Real-time PCR. 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. NLRP3 gene expression. Timepoint: At the beginning of the study and 28th day. Method of measurement: Real-time PCR. ASC gene expression. Timepoint: At the beginning of the study and 28th day. Method of measurement: Real-time PCR. Caspase-1gene expression. Timepoint: At the beginning of the study and after twenty-eight days of intervention. Method of measurement: Real-time PCR. 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. 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. Serum total antioxidant capacity. Timepoint: At the beginning of the study and after twenty-eight days of intervention. Method of measurement: Colorimetric. Serm malondialdehyde (MDA) level. Timepoint: At the beginning of the study and after twenty-eight days of intervention. Method of measurement: Colorimetric. 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. 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. 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. 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. 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. 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. Anthropometric indices. Timepoint: At the beginning of the study and after twenty-eight days of intervention. Method of measurement: Physical examination. Iran University of Medical Sciences Approved 2024-12-22 Research Ethics Committees of Iran University of Medical Sciences Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)