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IRCT20170104031773N3 IRCT 2019-06-09 Shahid Beheshti University of Medical Sciences Effect of sodium selenium administration on functional and cognitive scores in ischemic stroke Investigation of the sodium selenium administration on the level of inflammatory factors, oxidative stress and functional and cognitive scores in acute ischemic stroke patients 2019-04-21 anticipated 60 Complete https://irct.ir/trial/39366 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block random sampling will be used. In the present study, there are two groups (intervention group and control group). Therefore, four blocks will be used. According to the sample size (60 people in total, 30 in each group), 15 blocks of four will be considered. The random allocation of individuals to the groups under study will be done as follows: First, there are 15 envelopes containing four cards with ABCD Latin letters, the letters A and B = the intervention group, the letters C and D = will be considered as the control group. According to the inclusion criteria, the patients were asked to choose one of the 15 seals envelopes randomly and select a random card from the inside, which is based on the card's adhesive that determines the allocation of the individual to either of the two study groups, Blinding description: In this study, participants and the individual who evaluates the outcome are unaware of the allocation of drugs and placebo. Before starting a medication, it will be explained to each patient that ،they will be treated with an intravenous drug. But the patients do not know what medicine they have received. The physician is a neurological assistant who is not involved in the study design, interventions, and specific objectives under study. 3 Ischemic stroke. Intervention 1: 500µg Selenase injection vial contains 1.67mg sodium selenite pentahydrate (German biosyn company), receiving a dose of 2000 μg after admission and then 1000 μg for 5 days. Intervention 2: Placebo group, receive saline initially at a dose of 40cc and then 20cc for 5 days. Yes - There is a plan to make this available What will be shared: Part of the data is the main consequence of the study When: Start the access period 6 months after printing the results To whom: Researchers working in academia and industry Conditions: Therapeutic use Where to obtain: Leila Simani l.simani90@sbmu.ac.ir How to obtain: After submitting the request and checking the available items,The data is obtained Comments:
public Leila Simani
Loghman Hakim Hospital, Makhsoos St., Lashkar CUV.
Tehran Iran (Islamic Republic of) 1333631151 +98 21 5102 5182 l.simani90@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Leila Simani
Loghman Hakim Hospital, Makhsoos St., Lashkar CUV.
Tehran Iran (Islamic Republic of) 1333631151 +98 21 5102 5296 l.simani90@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with acute stroke 40 years 70 years Both Receiving antioxidants constantly (such as vitamin C and E) Receiving anti-inflammatory drugs constantly(steroids, nonsteroidal anti-inflammatory) Suffered from HIV and neurodegenerative diseases (e.g. Alzheimer's, Parkinson's, amyotrophic lateral sclerosis, multiple sclerosis) Systemic diseases such as Diabetes Mellitus, Renal Failure, Malignant Melanoma, Uremia,Myopathy, and Congestive Heart Failure Loss of consciousness level due to any reason except stroke (such as shock, alcohol consumption or intoxication) I63 Cerebral infarction Treatment - Drugs Placebo 500µg Selenase injection vial contains 1.67mg sodium selenite pentahydrate (German biosyn company), receiving a dose of 2000 μg after admission and then 1000 μg for 5 days. Placebo group, receive saline initially at a dose of 40cc and then 20cc for 5 days. The level of tumor necrosis factor alpha(TNF-α). Timepoint: At the beginning of the study (before the intervention), 1 month after the start of taking sodium selenite. Method of measurement: Blood sample. The level of superoxide dismutase (SOD). Timepoint: At the beginning of the study (before the intervention), 1 month after the start of taking sodium selenite. Method of measurement: Blood Sample. The level of glutathione peroxidase(GPx). Timepoint: At the beginning of the study (before the intervention), 1 month after the start of taking sodium selenite. Method of measurement: Blood Sample. Motor function and verbal. Timepoint: At the beginning of the study (before the intervention), 1 month after the start of taking sodium selenite. Method of measurement: National Institues of Health Stroke Scale Questionnaire. Cognitive performance. Timepoint: At the beginning of the study (before the intervention), 1 month after the start of taking sodium selenite. Method of measurement: Mini Mental State Examination Questionnaire. Degree of disability. Timepoint: At the beginning of the study (before the intervention), 1 month after the start of taking sodium selenite. Method of measurement: Modified Rankin Scale Questionnaire. Shahid Beheshti University of Medical Sciences Approved 2019-02-03 Ethics Committee of Shahid Beheshti University of Medical Sciences Velenjak St٬ Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)