Investigation of the sodium selenium administration on the level of inflammatory factors, oxidative stress and functional and cognitive scores in acute ischemic stroke patients

Evaluation of the sodium selenium administration on the level of inflammatory, oxidative and functional and cognitive scores in patients with cerebral ischemic stroke

Two arms parallel group randomized trial with blinded outcome assessment

This study will be carried out after obtaining permission from the ethics committee of Shahid Beheshti University of Medical Sciences and consent of the head of neurology department of Loghman Hakim Hospital as a clinical trial on patients with acute stroke. They will be randomly divided into two groups. 1. Selenium treatment group with a dose of 2000 μg after admission and then 1000 μg for 5 days. 2. Placebo group, receive saline initially at a dose of 40cc and then 20cc for 5 days. The blood sample and NIHSS, MRS, MMSE will be taken from patients at the time of entry and end of day 30.

Inclusion criteria: Patients with acute stroke Exclusion criteria: 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)

Acute ischemic stroke patients are divided into two groups of Selenium and placebo treatment, which is similar to the drug.

Level of tumor necrosis factor alpha(TNF-α), superoxide dismutase (SOD), glutathione peroxidase(Gpx)

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.

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.

Part of the data is the main consequence of the study

Start the access period 6 months after printing the results

Researchers working in academia and industry

Therapeutic use

Leila Simani l.simani90@sbmu.ac.ir

After submitting the request and checking the available items,The data is obtained