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IRCT20210101049905N1 IRCT 2021-01-15 Hamedan University of Medical Sciences Effect of Clcitriol in Ischemi stroke Evaluating the effect of calcitriol on serum level of inflammatory biomarkers in patients with ischemic stroke 2021-01-04 anticipated 78 Complete https://irct.ir/trial/53478 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients are randomly divided into intervention and control groups. The allocation of patients in the control and intervention groups is a random block, so that we put 2 sheets A and two sheets B in an envelope, and each time we remove one of the sheets, we place the patient in the control or intervention group, Blinding description: Patients are randomly divided into intervention and control groups. The allocation of patients in the control and intervention groups is a random block, so that we put 2 sheets A and two sheets B in an envelope, and each time we remove one of the sheets, we place the patient in the control or intervention group. The sheet is removed and will not be returned to the envelope until the sheets in the envelope are finished. 2 Ischemic Stroke. Intervention 1: Intervention group: After diagnosis by the relevant specialist and the existence of inclusion criteria and obtaining consent, patients are randomly divided into two intervention or control groups. The objectives of the study will be explained to the patients participating in the study and for the patients of the two groups receiving the drug and placebo, the possible beneficial effects, possible side effects and how to use the drug will be explained and only patients will enter the study with informed consent. In this study, patients with unconsciousness will enter the study with the consent of first-degree relatives. Patients will not be included in the study if patients do not have the conditions of full intellect and will and it is not possible to obtain the consent of their partner and guardian (father or paternal grandfather). Calcitriol and placebo are prepared orally. The consent form is given in Appendix 1. In the intervention group, patients are prescribed oral calcitriol at a dose of 1 microgram once a day for 5 days in addition to the standard treatment. Intervention 2: Control group: After diagnosis by the relevant specialist and the existence of inclusion criteria and obtaining consent, patients are randomly divided into two groups of intervention or control. The objectives of the study will be explained to the patients participating in the study and for the patients of the two groups receiving the drug and placebo, the possible beneficial effects, possible side effects and how to use the drug will be explained and only patients will enter the study with informed consent. In this study, patients with unconsciousness will enter the study with the consent of first-degree relatives. Patients will not be included in the study if patients do not have the conditions of full intellect and will and it is not possible to obtain the consent of their partner and guardian (father or paternal grandfather). Calcitriol and placebo are prepared orally. The consent form is given in Appendix 1. In the control group, patients receive placebo aqueous solution in addition to standard treatment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Mahdi Mahanpoor
No. 3873, Lale deadend, Olke alley, Imam khomeini street
Arak Iran (Islamic Republic of) 3813783873 +98 86 3224 2129 mahdymahanpoor@yahoo.com Hamedan University of Medical Sciences scientific Mahdi Mahanpoor
No. 3873, Lale deadend, Olke alley, Imam khomeini street
Arak Iran (Islamic Republic of) 3813783873 +98 86 3224 2129 mahdymahanpoor19@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age 18 to 85 years Focal neurological disorder Clinical diagnosis of acute ischemic stroke Radiological findings of MRI and CT are consistent with the clinical diagnosis of acute hemisphere stroke No other concomitant inflammatory disease Do not take drugs other than standard ischemic stroke treatments that alter the levels of the factors under consideration. No pregnancy and lactation Patients who have been hospitalized for the first 24 hours after a stroke. Patients suffering from ischemic stroke for the first time Do not use any combination with antioxidant effects in the past month No asthma and a history of anaphylactic shock 18 years 85 years Both Evidence based on acute or chronic intracerebral hemorrhage and cerebral aneurysm Existence of any etiology other than ischemia Existence of any cognitive or behavioral disorders that lead to the patient not cooperating. The patient's unwillingness to continue cooperating or taking the drug correctly Drug intolerance and side effects Consumption of any combination or drug with antioxidant effects except prescription drugs I63.00 Cerebral infarction due to thrombosis of unspecified precerebral artery Treatment - Drugs Placebo Intervention group: After diagnosis by the relevant specialist and the existence of inclusion criteria and obtaining consent, patients are randomly divided into two intervention or control groups. The objectives of the study will be explained to the patients participating in the study and for the patients of the two groups receiving the drug and placebo, the possible beneficial effects, possible side effects and how to use the drug will be explained and only patients will enter the study with informed consent. In this study, patients with unconsciousness will enter the study with the consent of first-degree relatives. Patients will not be included in the study if patients do not have the conditions of full intellect and will and it is not possible to obtain the consent of their partner and guardian (father or paternal grandfather). Calcitriol and placebo are prepared orally. The consent form is given in Appendix 1. In the intervention group, patients are prescribed oral calcitriol at a dose of 1 microgram once a day for 5 days in addition to the standard treatment. Control group: After diagnosis by the relevant specialist and the existence of inclusion criteria and obtaining consent, patients are randomly divided into two groups of intervention or control. The objectives of the study will be explained to the patients participating in the study and for the patients of the two groups receiving the drug and placebo, the possible beneficial effects, possible side effects and how to use the drug will be explained and only patients will enter the study with informed consent. In this study, patients with unconsciousness will enter the study with the consent of first-degree relatives. Patients will not be included in the study if patients do not have the conditions of full intellect and will and it is not possible to obtain the consent of their partner and guardian (father or paternal grandfather). Calcitriol and placebo are prepared orally. The consent form is given in Appendix 1. In the control group, patients receive placebo aqueous solution in addition to standard treatment Erythrocyte Sedimentation Rate. Timepoint: At the beginning of the study and 3 days after the end of the medication. Method of measurement: Westergren. C-Reactive Protein. Timepoint: At the beginning of the study and 3 days after the end of the medication. Method of measurement: latex agglutination. Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences Approved 2020-12-19 Ethics Committee of Hamadan University of Medical Sciences Research Ethics Committee,Vice Chancellor for Research and Technology, Medical Sciences university,Shahid Fahmideh Blvd., Hamedan Hamadan Iran (Islamic Republic of)