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IRCT20191020045162N1 IRCT 2020-03-12 Kermanshah University of Medical Sciences The effect of resveratrol on stroke Investigating the effect of resveratrol on therapeutic outcomes of acute ischemic stroke patient receiving r-tPA 2019-11-11 anticipated 60 Complete https://irct.ir/trial/43344 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization method is used since patients go to the doctors over time, and we aim to have both studied groups receive equal treatment. To do so, we use a block size of 4 and for the sample size of 40 a block size of 4 will be generated. Then, in the next step, beside block randomization, each generated random sequence will be written on a separate card and placed in non-transparent blocks, like block number 1 sequence AABB. They are used based on numerical orders allocated to each block, and block sequence for the studied patients is used. This procedure will be carried out till the end of the study. In order to use the random allocation method, a methodologist places the blocks in sequence, handles the blocking and numbering process according to the required sample size, and shares them with the related department’s receptionist who is not aware of the studied treatments. Then he/she informs the patients the purpose of this study and investigates the input and output criteria of the study. In the final step, the patients will be assigned to the related studied group by receiving a code from the receptionist and will be referred to a doctor, Blinding description: After a random selection of patients To hide groups receiving treatment, the capsule understudy will be similar in shape (First level blinding) and to blind the therapist, Drugs are prepackaged in envelopes marked A and B and depending on which code the patient goes to see a doctor will receive the desired treatment. 3 Ischemic stroke. Intervention 1: Intervention group: Patients with stroke receiving r-tPA who receive oral resveratrol capsule (150 mg every eight hours) and herbal medicine purchased from overseas and Packaged by pharmacists at Kermanshah School of Pharmacy. Intervention 2: Control group: Patients with stroke receiving r-tPA who receive placebo(Lactulose oral capsule every eight hours) and Packaged by pharmacists at Kermanshah School of Pharmacy. Yes - There is a plan to make this available What will be shared: The amount of changes in MRS and Bartel index in the two groups When: 6 month after publishing article To whom: For the public Conditions: For further research Where to obtain: Imam Reza Hospital Kermanshah - Dr. Payam Sariaslani How to obtain: Applying to the hospital and Dr. Sariaslani will then announce the outcome. Comments:
public Payam Sariaslani
Parsatar Blvd, Imam Reza Hospital
Kermanshah Iran (Islamic Republic of) 6714415333 +98 83 3427 6303 drdparsa68@gmail.com Kermanshah University of Medical Sciences scientific Payam Sariaslani
Parsatar Blvd, Imam Reza Hospital
Kermanshah Iran (Islamic Republic of) 6714415333 +98 83 3427 6303 drdparsa68@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) َAll of acute ischemic stroke patient reciving r-tPA. 18 years 90 years Both Pregnant patient Patients who received r-tPA more than 24 hours ago Previous cerebral hemorrhage and previous stroke I67 Other cerebrovascular diseases Treatment - Drugs Placebo Intervention group: Patients with stroke receiving r-tPA who receive oral resveratrol capsule (150 mg every eight hours) and herbal medicine purchased from overseas and Packaged by pharmacists at Kermanshah School of Pharmacy. Control group: Patients with stroke receiving r-tPA who receive placebo(Lactulose oral capsule every eight hours) and Packaged by pharmacists at Kermanshah School of Pharmacy. NIHSS : National Institutes of Health Stroke Scale. Timepoint: Symptoms onset - 24 hours later - discharge time. Method of measurement: Using a checklist and a special form that will be filled in according to the patient's history and examination. Modified Rankin Scale (MRS). Timepoint: Before symptoms begin - three months later. Method of measurement: Based on specific forms that the patient or his / her companions will be asked to telephone or in person. Barthel Index. Timepoint: Three months later. Method of measurement: Based on specific forms that the patient or his / her companions will be asked by phone or in person. Kermanshah University of Medical Sciences Approved 2019-10-20 Ethics committee of kermanshah university of medical siences Nursing Blvd - Imam reza hospital kermanshah Kermanshah Iran (Islamic Republic of)