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IRCT20180201038585N11 IRCT 2021-08-23 Bagheiat-allah University of Medical Sciences Effect of functional food mixtures on serum levels of inflammatory cytokines in patients with covid-19 Effect of functional food mixtures on serum levels of inflammatory cytokines and laboratory findings in patients with covid-19 2021-09-05 anticipated 60 Complete https://irct.ir/trial/57338 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was performed using groups of 4 (blocks) that were similar in terms of sex and age by a random number table and trained by a third person and assigned to intervention and control groups to receive one of the treatments. Concealment was also performed using sealed envelopes so that researchers and participants were unaware of the allocation, Blinding description: For blinding, regular food and functional food will be placed in the same 30 grams sachets. The sachets are then placed in paper boxes and will receive a special code from the label company. Ordinary and functional food codes will remain with the company until the end of the study to blind researchers, laboratory staff, and patients. 3 Covid-19. Intervention 1: Intervention group: At the beginning of the study, patients in the intervention group will receive 30-gram sachets of functional food (functional soup). Patients in the intervention group will be asked to consume a 30-gram packet of functional food (functional soup) daily in the morning for 1 week. In order to increase compliance, patients were asked on a daily basis. Intervention 2: Control group: Patients in the control group will receive 30-gram packages of regular food (barley soup) at the beginning of the study. Patients in the control group will be asked to consume a 30-gram packet of regular food (barley soup) daily in the morning for 1 week. In order to increase compliance, patients are asked on a daily basis. 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 No decision has been made yet
public Karim Parastouei
Baqiyatallah University of Medical Sciences, sheikh bahaei Ave, Mollasadra st
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8755 5470 parastouei@bmsu.ac.ir Bagheiat-allah University of Medical Sciences scientific Karim Parastouei
Baqiyatallah University of Medical Sciences, sheikh bahaei Ave, Mollasadra st
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8755 5470 parastouei@bmsu.ac.ir Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) The need for hospitalization with clinical signs in favor of coronavirus infection includes one or more of the following : The patient experiences a decrease in oxygen saturation of less than 93% A drop in systolic blood pressure less than 100 or a drop in blood pressure of 30 mm Hg from the patient's previous normal systolic pressure fever Dry cough the positive result of CRP index Laboratory indexes included : CRP , ESR 20 years 70 years Both Patient dissatisfaction Lack of proper conditions for oral feeding U07.1 COVID-19, virus identified Treatment - Other Treatment - Other Intervention group: At the beginning of the study, patients in the intervention group will receive 30-gram sachets of functional food (functional soup). Patients in the intervention group will be asked to consume a 30-gram packet of functional food (functional soup) daily in the morning for 1 week. In order to increase compliance, patients were asked on a daily basis. Control group: Patients in the control group will receive 30-gram packages of regular food (barley soup) at the beginning of the study. Patients in the control group will be asked to consume a 30-gram packet of regular food (barley soup) daily in the morning for 1 week. In order to increase compliance, patients are asked on a daily basis. The amount of inflammatory and anti-inflammatory cytokines (Il-1β، Il-6، TNFα،IL-10، IL-4 ,IFNƳ ). Timepoint: At the start and after 1 week of study. Method of measurement: Through intravenous blood samples and commercial kits. Laboratory findings. Timepoint: At the beginning and after 1 week of study. Method of measurement: Through intravenous blood samples and commercial kits. Bagheiat-allah University of Medical Sciences Approved 2021-05-10 Ethics Committee of Baqiyatallah University of Medical Sciences Mollasadra st Ave, Vannak Sq Tehran Tehran Iran (Islamic Republic of)