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IRCT20160305026917N2 IRCT 2021-05-25 Birjand University of Medical Sciences The effect of jujube and saffron supplement on Covid-19 Investigating the effect of oral supplementation containing jujube and saffron on recovery and controlling the symptoms of patients with covid-19 2021-07-21 anticipated 60 Complete https://irct.ir/trial/56417 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomized double-blind controlled clinical trial randomization using random allocation software According to the randomization, each supplement or placebo sample is assigned a number and the patient will not be informed about taking the drug or placebo (Numbers from 1 to 60), Blinding description: Patients will be notified to participate in the study and obtaining a consent form but they will be blind to the supplements or placebo. During the study, with the exception of the pharmacist (who has no role in the clinical study and evaluations), the rest of the project partners, including infectious disease specialists, radiologists, nurses, and project analysts, will not know how the drug and placebo are allocated. Supplement and placebo are also identical in appearance so that they are not recognizable to patients. 3 Covid-19. Intervention 1: Intervention group: Standard treatment will be performed and a saffron-jujube supplement will be prescribed with it for 30 patients. The duration of the intervention is 2 weeks and the received dose is equal to 15 ml of the supplement three times a day after each meal orally. On the zero-day, during consumption, and on the 7th and 14th days of the intervention, the relevant variables are measured. Intervention 2: Control group: Standard treatment will be performed and placebo will be prescribed with it for 30 patients. The placebo does not contain saffron and jujube. The duration of the intervention is 2 weeks and the received dose is equal to 15 ml of the supplement three times a day after each meal orally. On the zero-day, during consumption, and on the 7th and 14th days of the intervention, the relevant variables are measured. 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 Sayyedeh Fatemeh Askari
Ghaffari Ave.
Birjand Iran (Islamic Republic of) 9717853577 +98 56 3238 1919 sfaskari98@gmail.com Birjand University of Medical Sciences scientific Sayyedeh Fatemeh Askari
Ghaffari Ave.
Birjand Iran (Islamic Republic of) 9717853577 +98 56 3238 1919 sfaskari98@gmail.com Birjand University of Medical Sciences Iran (Islamic Republic of) Clinical or paraclinical confirmation of disease Absence of underlying disease including diabetes, thyroid disorders, cardiovascular, autoimmune, and hemorrhagic and other lung diseases No pregnancy and breastfeeding. 15 years 70 years Both Patients with severe forms of the disease (patients under ventilator, patients with oxygen saturation below 88 mm Hg, and patients admitted to the ICU The patient's unwillingness to continue participating in the project Sensitivity to the components of the supplement. U07.1 Covid-19 Treatment - Drugs Placebo Intervention group: Standard treatment will be performed and a saffron-jujube supplement will be prescribed with it for 30 patients. The duration of the intervention is 2 weeks and the received dose is equal to 15 ml of the supplement three times a day after each meal orally. On the zero-day, during consumption, and on the 7th and 14th days of the intervention, the relevant variables are measured. Control group: Standard treatment will be performed and placebo will be prescribed with it for 30 patients. The placebo does not contain saffron and jujube. The duration of the intervention is 2 weeks and the received dose is equal to 15 ml of the supplement three times a day after each meal orally. On the zero-day, during consumption, and on the 7th and 14th days of the intervention, the relevant variables are measured. Investigation of radiological changes. Timepoint: 0 (before the intervention), 7th, 14th day after intervention. Method of measurement: Computed tomography scan. Coughing. Timepoint: 0 (before the start of the intervention) - 14th day after intervention. Method of measurement: Based on Visual Analogue Scale. Complete blood count indices. Timepoint: 0 (before the intervention), 7th, 14th day after intervention. Method of measurement: Complete blood count test. Duration of hospitalization. Timepoint: After the patient is discharged. Method of measurement: The number of days of hospitalization. Body temperature. Timepoint: 0 (before the start of the intervention) - 14th day after intervention. Method of measurement: Thermometer. Birjand University of Medical Sciences Approved 2021-05-17 Ethics committee of Birjand University of Medical Sciences Ghaffari Ave. Birjand South Khorasan Iran (Islamic Republic of)