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IRCT20170315033086N5 IRCT 2019-05-05 Shahid Beheshti University of Medical Sciences Circulatory Cytokine Profiles of Ischemic Stroke Patients after Treatment with strowell capsules Investigation of Anti-inflammatory Effects of strowell capsules on Plasma Inflammatory Factors in Ischemic Stroke Patients: A Randomized, Double-blind Placebo-controlled Trial 2017-05-01 anticipated 80 Complete https://irct.ir/trial/25619 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is designed based on four-sized block randomization procedure. A non-ordered computer sequence list including the patient-assigned code and the order of recruitment is generated by an epidemiologist. Given the block size of 4, there are 6 possible ways to equally assign participants to each treatment group. Therefore recruitment of participants to each treatment category is randomized and unpredictable. Following this randomization, an equal number of participants is randomly assigned to each treatment group, Blinding description: Patient allocation and sequencing are done blindly. All the members of the staff who are involved in performing the enrollment, physicians, nurses and the investigation team as well as patients and their guardians, are masked. The research group is uninformed of drug and/or placebo prescription and its dosage. Codes will be written on the sealed envelopes and the medication bottles. Following patient assessment by the doctor, according to the admission sequence, the envelopes with the same number will be opened. Subsequently, the patients are going to be handed a bottle that could be the drug or placebo based on the assigned code. Therefore, the patient is unbeknownst whether the intervention is strowell capsules or the placebo. 2 Ischemic stroke. Intervention 1: Intervention group: strowell capsules receiving group, 1 month, 3 times/day, Oral Administration (800 mg). Intervention 2: Control group: Placebo group,1 month, 3 times/day, Oral (800 mg). Yes - There is a plan to make this available What will be shared: collected de-identified IPD, IPD collected for the primary outcome measure only When: De-identified data will be available starting from April, 2021 To whom: Academics employed at various research/university institutions and the industry. Conditions: No specific condition are specified. Where to obtain: Behnam Safarpour Lima, Shahid Madani St., Tehran, Iran, Tel: +982173433000 Mob. 091229811576 How to obtain: 1- The applicant would be asked to provide a written formal request letter, containing the importance of the data and the project processes. 2- Following the receipt of request letter, the data would be provided in no more than two weeks. Comments:
public Behnam Safarpour Lima
Shahid Madani St., Tehran, Iran
Tehran Iran (Islamic Republic of) 1617948615 +98 21 7343 3000 info@ehmc.ir Shahid Beheshti University of Medical Sciences scientific Behnam Safarpour Lima
Shahid Madani St., Tehran,
Tehran Iran (Islamic Republic of) 1617948615 +98 21 7343 3000 info@ehmc.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Diagnosis, based on neurological diagnostic signs and confirmed by Magnetic Resonance Imaging (MRI) National Institutes of Health Stroke Scale (NIHSS) should be in 4 - 20 range at the time of admission. Body mass index (BMI) should be in 20-25 range No inflammatory diseases 40 years 80 years Both Hemorrhagic stroke transient ischemic attack (TIA) History of gastrointestinal bleeding History of sensitivity to NSIADs Previous stroke Myocardial infarction within the previous 48 hours Kidney and liver failure Immunosuppressive medications Stroke patients who have received tissue plasminogen activator (tPA). Rheumatoid and autoimmune diseases Malignancies Pregnancy or lactation I63.9 Cerebral infarction, unspecified Treatment - Drugs Treatment - Drugs Intervention group: strowell capsules receiving group, 1 month, 3 times/day, Oral Administration (800 mg) Control group: Placebo group,1 month, 3 times/day, Oral (800 mg) Stroke intensity. Timepoint: At the commencement of the investigation and after taking the strowell capsules. Method of measurement: NIH Stroke Scale questionnaire for quantifying stroke severity (11 items are included, level of consciousness, horizontal eye movement, visual field test, facial palsy, motor arm and motor leg, limb ataxia, sensory, language, speech, extinction and inattention). Pro- and anti-inflammatory plasma markers. Timepoint: At the investigation commencement and after the intervention. Method of measurement: ELISA assay kit. Shahid Beheshti University of Medical Sciences Approved 2017-01-03 Ethics committee of Shahid Beheshti University of Medical Sciences, School of Medicine Ground floor, medical faculty, Koodakyar Alley, Daneshjoo Blvd, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)