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IRCT20200416047104N1 IRCT 2020-04-23 Shahre-kord University of Medical Sciences Effect of pomegranate tea on symptom relief of COVID-19 patients The effect of pomegranate tea on symptom relief of COVID-19 patients: a double-blind randomized clinical trial study 2020-04-20 anticipated 66 Complete https://irct.ir/trial/47251 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly assigned to study by randomized class blocking according to the respiratory support groups they received (no need for respiratory support, respiratory support with low oxygen flow, respiratory support with high oxygen flow, respiratory support with oxygen storage, non-invasive ventilation) In four-person blocks, they are assigned to groups A and B and randomly using the software. Patient allocation will be blinded and clinical researchers will not be aware of the individual intervention group, Blinding description: In this study, all participants in the study, physicians and nurses responsible for collecting patients' clinical and laboratory data, were unaware of the intervention (placebo or drug) that each person received; placebo by oral and flavoring similar to the drug. Participants in the study and nurses are unaware of the presence of pomegranate extract. All medications will be coded by a pharmacognosy specialist, and randomization will be performed by the same person as described in the relevant section, and none of the colleagues in charge of tracking patients will know about even the groups of patients. N/A COVID-19. Intervention 1: Intervention group: Participants in the intervention group receive 4 times a day (after each meal and before bedtime) and 10 ccs of pomegranate syrup for 21 days each time, in addition to standard treatment. Pomegranate tea is prepared by dilution 10 ccs of pomegranate syrup in 50 to 100 cc of warm boiled water and kept in the mouth for a while before swallowing. Intervention 2: Control group: In addition to standard treatment, the control group receives a placebo in completely similar conditions. The placebo will be produced in terms of taste and color similar to the original drug and will be used in completely similar conditions. Yes - There is a plan to make this available What will be shared: All potential data can be shared after blinding When: Six mounts after publishing To whom: Researchers working in academic institutions Conditions: For research purposes and meta-analysis studies Where to obtain: Dr. Zahra lorigooini, Medical Plants Research Center, School of Medicine, Shahrekord University of Medical Sciences, Rahmatieh How to obtain: Official letter to the researchers Comments:
public Dr. Zahra Lorigooini
Medical Plants Research Center, School of Medicine, Shahrekord University of Medical Sciences, Rahmatieh
Shahrekord Iran (Islamic Republic of) 8813833435 +98 38 3334 6722 zahralorigooini@gmail.com Shahre-kord University of Medical Sciences scientific Dr. Fereidoun Rahmani
Hajar Hospital, Parastar Street
Shahrekord Iran (Islamic Republic of) 8816854633 +98 38 3225 2416 frahmani@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Positive diagnostic specimen on RT-PCR Men or non-pregnant women over 18 years of age Significant involvement in pulmonary CT scan with pneumonia diagnosis Oxygen saturation (Sao2) of blood less than or equal to 93% in room air Respiratory rate above 24 per minute 18 years no limit Both Taking medications: (Amitriptyline, Codeine, Desipramine, Flecainide, Fluoxetine, Ondansetron, Tramadol) Pregnancy and lactation U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: Participants in the intervention group receive 4 times a day (after each meal and before bedtime) and 10 ccs of pomegranate syrup for 21 days each time, in addition to standard treatment. Pomegranate tea is prepared by dilution 10 ccs of pomegranate syrup in 50 to 100 cc of warm boiled water and kept in the mouth for a while before swallowing. Control group: In addition to standard treatment, the control group receives a placebo in completely similar conditions. The placebo will be produced in terms of taste and color similar to the original drug and will be used in completely similar conditions. Time to clinical improvement. Timepoint: Every day after randomization. Method of measurement: Patients' medical records. Time to clinical deterioration. Timepoint: Every day after randomization. Method of measurement: Patients' medical records. Duration of Hospitalization. Timepoint: Every day after randomization. Method of measurement: Patients' medical records. Mortality. Timepoint: 21th day after randomization. Method of measurement: Patients' medical records. Clinical improvement in first 7 days of intervention. Timepoint: 7th day after randomization. Method of measurement: Patients' medical records. Fever. Timepoint: Every day after randomization. Method of measurement: Thermometer. Respiratory rate. Timepoint: Every day after randomization. Method of measurement: Clinical observation and examination. Oxygen saturation. Timepoint: Every day after randomization. Method of measurement: Pulse Oximeter. Systolic blood pressure. Timepoint: Every day after randomization. Method of measurement: Clinical observation and examination. Duration of respiratory support. Timepoint: Every day after randomization. Method of measurement: Patients' medical records. Cough. Timepoint: Every day after randomization. Method of measurement: Clinical observation and history taking. Dyspnea. Timepoint: Every day after randomization. Method of measurement: Clinical observation and history taking. Fatigue. Timepoint: Every day after randomization. Method of measurement: Clinical observation and history taking. Myalgia. Timepoint: Every day after randomization. Method of measurement: Clinical observation and history taking. Headache. Timepoint: Every day after randomization. Method of measurement: Clinical observation and history taking. Sore throat. Timepoint: Every day after randomization. Method of measurement: Clinical observation and history taking. Chills. Timepoint: Every day after randomization. Method of measurement: Clinical observation and history taking. Gastrointestinal adverse events. Timepoint: Every day after randomization. Method of measurement: Clinical observation and history taking. Thirsty. Timepoint: Every day after randomization. Method of measurement: Clinical observation and history taking. Duration of respiratory support. Timepoint: Every day after randomization. Method of measurement: Patients' medical records. Transmission to ICU. Timepoint: Every day after randomization. Method of measurement: Patients' medical records. SARS-CoV-2 test result. Timepoint: 21th day after randomization. Method of measurement: RT-PCR. Blood cell count. Timepoint: Two days in between after randomization. Method of measurement: The complete blood count (CBC). CRP level. Timepoint: Two days in between after randomization. Method of measurement: Blood test. Serum creatinine. Timepoint: Two days in between after randomization. Method of measurement: Blood test. Lactate dehydrogenase. Timepoint: Two days in between after randomization. Method of measurement: Blood test. Ferritin. Timepoint: Two days in between after randomization. Method of measurement: Blood test. Shahre-kord University of Medical Sciences Approved 2020-04-12 Ethics committee of Shahrekord University of Medical Sciences Shahrekord University of Medical Sciences, Kashani Blvd Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)