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IRCT20210614051574N4 IRCT 2021-09-02 Esfahan University of Medical Sciences Lycopene and flow mediated dilatation index and blood pressure The effect of lycopene supplementation on lipid profile and flow mediated dilatation index and blood pressure in patients with ischemic heart failure 2021-09-22 anticipated 50 Complete https://irct.ir/trial/58343 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: Experiment participants as well as the facilitator will not be informed of how the two groups are divided. A person who has no role in patient selection and data analysis encodes placebo and drug tablets and puts them in a box, and these boxes, each with a code, are given to patients by the project manager who does not know how to code. After the analysis, patient coding will be defined. 2-3 Heart failure. Intervention 1: Intervention group: Patients in this group will receive lycopene tablets made by Vitabiotics company once a day for 8 weeks. Variables will be measured before and after taking the medication. Intervention 2: Control group: Patients in this group will receive placebo tablets containing starch once a day for 8 weeks. Variables will be measured before and after taking the medication. Yes - There is a plan to make this available What will be shared: All data can be shared after people have requested. When: Six months after publishing the results. To whom: Academic researchers Conditions: Scientific uses Where to obtain: Website of the Research Committee of Isfahan University of Medical Sciences How to obtain: Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data. Comments:
public Masoumeh Sadeghi
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0042 parsa.alinezhad85@gmail.com Esfahan University of Medical Sciences scientific Masoumeh Sadeghi
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0042 parsa.alinezhad85@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) The person's desire to participate in the project Heart failure due to myocardial infarction with a ejection fraction below 40% Having a body mass index between 18.5 to 30 18 years no limit Both Suffering from autoimmune, respiratory, acute phase of cancer or surgery, infectious and liver diseases and diabetes Having other heart diseases Taking corticosteroid and immunosuppressive drugs Consumption of supplements with antioxidant properties I50 Heart failure Treatment - Drugs Placebo Intervention group: Patients in this group will receive lycopene tablets made by Vitabiotics company once a day for 8 weeks. Variables will be measured before and after taking the medication. Control group: Patients in this group will receive placebo tablets containing starch once a day for 8 weeks. Variables will be measured before and after taking the medication. Flow mediated dilatation index. Timepoint: Before and 8 weeks after interventions. Method of measurement: Ultrasound. Blood pressure. Timepoint: Before and 8 weeks after interventions. Method of measurement: Blood pressure monitor. Esfahan University of Medical Sciences Approved 2020-12-26 Ethics committee of Esfahan University of Medical Sciences Esfahan University of Medical Sciences, Hezar Jarib Ave., Esfahan Isfahan Isfehan Iran (Islamic Republic of)