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IRCT20180803040679N1 IRCT 2019-01-03 Mashhad University of Medical Sciences effects of curcumine in stroke Evaluation of the effect of Nano Micelle curcumin of patient with ischemic stroke: triple-blind placebo-controlled randomized clinical trial 2019-01-04 anticipated 80 Complete https://irct.ir/trial/36199 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study used simple randomization. Randomization units consisted of individuals. We used closed pockets for randomization, Blinding description: Study participants: patients will be divided into intervention and placebo groups. Placebo and the intervention group drugs will be identical and patients won`t notice the difference. Investigators: a group of investigators will evaluate patients. Investigators will be provided with placebo and Curcumin which are identical, However, Drugs will be labeled as A and B, Which presents each study groups. statistical analyzer: Data will present to statistical analyzers as A & B groups. They will be blinded about the intervention and placebo groups. 3 Acute ischemic stroke. Intervention 1: Intervention group: The intervention group will receive 80mg of Curcumin pearl everyday for 8 weeks accompanied with acute ischemic stroke treatments. The first dose will be administered during the first 12 hour of ischemic stroke occurrence. The brand name is SinaCurcumin®. Marketing Authorization holder is Exir Nano Sina Co. and the drug is manufactured by Minoo Co. IRC: 1228225765. Intervention 2: Control group: The control group will receive a placebo, which is identical to the curcumin, once a day for 8 weeks and the routine treatment for acute ischemic stroke. Yes - There is a plan to make this available What will be shared: these files will be presented upon request: Patients` data after removing their identity, Research protocol, statistical methods used in this study and written informed consent. When: data will be available 3 months after the article has been published To whom: Any researcher who needs our data to accomplish his research Conditions: The researcher should use these data only in their related research and should mention the reference Where to obtain: researchers should send their request to Mr. Reza Rahimzadeh Oskooie via email. Email: rahimzadehr901@mums.ac.ir How to obtain: Researchers should send their request for data that includes their reasons for using the data and their study protocols and aims. The request will be answered during 14 business days Comments:
public Fariborz Rezaeitalab
No 46, Qods 14, Felestin Ave
Mashhad Iran (Islamic Republic of) 91766-76757 +98 51 3760 5917 rezaeitalabf@mums.ac.ir Mashhad University of Medical Sciences scientific Fariborz Rezaeitalab
No 46, Qods 14, Felestin Ave
Mashhad Iran (Islamic Republic of) 91766-76757 +98 51 3760 5917 rezaeitalabf@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age between 50-80 years First ever stroke patients Ischemic stroke GCS<13 NIHSS=4-25 MRS<2 before the stroke Stroke occurrence within prior 12 hours. 50 years 80 years Both Fever at first presentation Presence of other inflammatory conditions Immunosuppressive drug consumption Death within the first week of the study Presence of bedsore during follow-up Occurrence of myocardial infarction during the study follow-up Pregnancy TIA 3 month prior to study Massive brain infarction Declining to participate History of allergy to Turmeric Advanced hepatic conditions malabsorption syndrome History of diabetes Receiving rTPA Mechanical thrombectomy during the study follow-up Presence of dementia Craniotomy during the study follow-up BMI more than 35 Cigarette smoking Alcohol consumption I63.2 Cerebral infarction due to unspecified occlusion or stenosis of precerebral arteries Treatment - Drugs Treatment - Drugs Intervention group: The intervention group will receive 80mg of Curcumin pearl everyday for 8 weeks accompanied with acute ischemic stroke treatments. The first dose will be administered during the first 12 hour of ischemic stroke occurrence. The brand name is SinaCurcumin®. Marketing Authorization holder is Exir Nano Sina Co. and the drug is manufactured by Minoo Co. IRC: 1228225765 Control group: The control group will receive a placebo, which is identical to the curcumin, once a day for 8 weeks and the routine treatment for acute ischemic stroke. Stroke severity. Timepoint: before intervention, 4 days, 8 weeks and 3 month after intervention. Method of measurement: using NIHSS. Degree of disability/dependence. Timepoint: before intervention, 4 days, 8 weeks and 3 month after intervention. Method of measurement: using MRS. Activities of Daily Living. Timepoint: before intervention, 4 days, 8 weeks and 3 month after intervention. Method of measurement: Barthel index. Seizure. Timepoint: before intervention, 4 days, 8 weeks and 3 month after intervention. Method of measurement: according to clinical presentations. Mashhad University of Medical Sciences Approved 2018-12-24 Ethics committee of Mashhad University of Medical Sciences Faculty of medicine, Mashhad university of medical sciences Campus, Azadi square Mashhad Razavi Khorasan Iran (Islamic Republic of)