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IRCT20221021056258N1 IRCT 2022-11-13 Mashhad University of Medical Sciences Biological and Pharmacological Activities Of Squalene In Acute Myocardial Infarction Biological and Pharmacological Activities Of Squalene,Potential Uses In Acute Myocardial Infarction 2022-11-06 anticipated 90 Complete https://irct.ir/trial/66463 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, the random sequence is generated using www.randomization.com. Then, based on the size of the research sample, a number of envelopes with aluminum wrappers (in order not to make the contents of the envelopes unclear) are prepared and each of the random sequences created is recorded on a card and the cards are placed inside the envelopes. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lids of the envelopes are glued and placed in a box. At the time of patient sampling, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed. 2 Condition 1: Acute myocardial infarction. Condition 2: Heart failure. Intervention 1: Intervention group: In addition to routine treatments, the group receiving squalene drops will receive sublingually and 4 times a day with a dose of 5 drops each time for 5 days. The concentration of the drug is ten milligrams per milliliter and with It is produced by the collaboration of Mashhad Faculty of Medical Sciences and professors of pharmacy and chemical engineers of the Faculty of Basic Sciences of Ferdowsi University of Mashhad.Squalene extracted from vegetable oils is a non-toxic and biocompatible lipid that has various applications in the food and pharmaceutical industries. Also, this compound is a precursor of cholesterol and one of the natural components of human skin and protects it against radiation. So far, its anti-inflammatory, antioxidant and anti-tumor properties have been investigated and proven in animal studies, and no toxicity and or adverse effects have not been reported in animals. Intervention 2: Control group: Only recipients of routine treatments for acute myocardial infarction and heart failure. 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 We do not have a plan to publish yet.
public Alireza fazeli
No. 5, Saremi Ave., Vakilabad Blvd., Mashhad Town
Mashhad Iran (Islamic Republic of) 476876543564 +98 51 3843 5676 fazelia981@mums.ac.ir Mashhad University of Medical Sciences scientific Alireza fazeli
No. 5, Saremi Ave., Vakil abad Blvd., Mashhad Town
Mashhad Iran (Islamic Republic of) 6547698743 +98 51 3832 4567 fazelia981@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients 18 to 80 years old Patients who have been diagnosed with ST segment elevation myocardial infarction and have undergone successful vascularization with angioplasty in the vessel related to the infarct. Ejection fraction less than forty percent in the field of acute Myocardial infarction 18 years 80 years Both Ventricular arrhythmia Congenital heart disease Suspected or documented history of heart failure or decreased ejection fraction (EF) of the left ventricle CABG candidate patients or previous CABG history GFR less than 30 People with autoimmune diseases or connective tissue disease People with cancer Pregnant and lactating women Psychiatric patients and people who cannot complete the one-month clinical follow-up during the study. I21.0 I50 ST elevation (STEMI) myocardial infarction of anterior wall Heart failure Treatment - Drugs Treatment - Other Intervention group: In addition to routine treatments, the group receiving squalene drops will receive sublingually and 4 times a day with a dose of 5 drops each time for 5 days. The concentration of the drug is ten milligrams per milliliter and with It is produced by the collaboration of Mashhad Faculty of Medical Sciences and professors of pharmacy and chemical engineers of the Faculty of Basic Sciences of Ferdowsi University of Mashhad.Squalene extracted from vegetable oils is a non-toxic and biocompatible lipid that has various applications in the food and pharmaceutical industries. Also, this compound is a precursor of cholesterol and one of the natural components of human skin and protects it against radiation. So far, its anti-inflammatory, antioxidant and anti-tumor properties have been investigated and proven in animal studies, and no toxicity and or adverse effects have not been reported in animals. Control group: Only recipients of routine treatments for acute myocardial infarction and heart failure. Ejection fraction. Timepoint: Patients undergo echocardiography in the first 24 hours before starting the drug and then after 30 days. Method of measurement: Echocardiography. Wall motion abnormality. Timepoint: Before starting the medicine and also thirty days after starting the medicine. Method of measurement: Echocardiography. Diastolic dysfunction. Timepoint: Before starting the medicine and also thirty days after starting the medicine. Method of measurement: Echocardiography. Pulmonary arterial pressure. Timepoint: Before starting the medicine and also thirty days after starting the medicine. Method of measurement: Echocardiography. Valvular Dysfunction. Timepoint: Before starting the medicine and also thirty days after starting the medicine. Method of measurement: Echocardiography. Laboratory factors such as complete blood cell count. Timepoint: Before starting the drug and after thirty days from the start of the drug. Method of measurement: Laboratory kit. Mashhad University of Medical Sciences Approved 2022-04-11 Ethics committee of Mashhad University of Medical Sciences Imam reza hospital., Ahmadabad Blvd., Mashhad Town Mashhad Razavi Khorasan Iran (Islamic Republic of)