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IRCT20200802048267N1 IRCT 2020-10-20 Esfahan University of Medical Sciences Propolis supplementation AND Coronavirus The effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial 2020-08-22 anticipated 80 Complete https://irct.ir/trial/50162 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible participants will be randomly assigned to either the propolis group or the placebo group. Randomization will be performed in a 1:1 ratio with the use of block sizes of 4, with stratification according to the gender. Randomization sequences will be prepared by the study pharmacist with the use of a random number table, Blinding description: Assignment of participants to the study groups will be concealed from participants and investigators, with the exception of the study pharmacist and care provider, until the end of the study and data analysis. The study pharmacist who will be aware of the assignments will be prepared the placebo tablets similar to the propolis tablet in color, odor, taste, shape, size, and weight. Drug containers will be the same in terms of shape, color, odor, size, and weight and will be kept inside numbered, opaque, and sealed envelopes which will be completely impermeable to light. 2 covid 19. Intervention 1: Intervention group: Participants in the intervention group will receive an identical propolis tablet (containing 300 mg Iranian green propolis) three times a day, before breakfast, lunch, and dinner, for 2 weeks. All tablets are prepared by the Reyhan Naghsh Jahan Pharmaceutical Co., Isfahan, Iran. Intervention 2: Control group: Participants in the control group will receive an identical placebo tablet (300 mg microcrystalline cellulose ) three times a day, before breakfast, lunch, and dinner, for 2 weeks. All tablets are prepared by the Reyhan Naghsh Jahan Pharmaceutical Co., Isfahan, Iran. Yes - There is a plan to make this available What will be shared: The non-identifiable individual participant data collected in this study will be shared. Also, The protocol, results, and statistical analysis of the current study will be published in the relevant articles. When: The non-identifiable individual participant data will become available after the publication of the relevant articles. To whom: The non-identifiable individual participant data will become available to other researchers in academic institutions. Conditions: The non-identifiable individual participant data can only be used for research. Where to obtain: The non-identifiable individual participant data will be obtainable by sending an e-mail to Mr. Karim Sohrabi (Email: sohrabi@mail.mui.ac.ir). How to obtain: Other researchers in academic institutions can send their request by e-mail to Mr. Karim Sohrabi (Email: sohrabi@mail.mui.ac.ir). The data will be sent to them after consulting and approving the research team. Comments:
public Karim Sohrabi
Alzahra Hospital, Soffeh Avenue, Isfahan
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3822 2003 sohrabi@mail.mui.ac.ir Esfahan University of Medical Sciences scientific Karim Sohrabi
Alzahra Hospital, Soffeh Avenue, Isfahan
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3822 2003 sohrabi@mail.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) A willing to participate with written informed consent The diagnosis of coronavirus based on the PCR test. 18 years 75 years Both Current use of warfarin Current use of Propolis Supplement Presence of sensitivity to bee products U07.1 Covid-19 Treatment - Drugs Placebo Intervention group: Participants in the intervention group will receive an identical propolis tablet (containing 300 mg Iranian green propolis) three times a day, before breakfast, lunch, and dinner, for 2 weeks. All tablets are prepared by the Reyhan Naghsh Jahan Pharmaceutical Co., Isfahan, Iran. Control group: Participants in the control group will receive an identical placebo tablet (300 mg microcrystalline cellulose ) three times a day, before breakfast, lunch, and dinner, for 2 weeks. All tablets are prepared by the Reyhan Naghsh Jahan Pharmaceutical Co., Isfahan, Iran. Respiratory Rate. Timepoint: day 1 and day 14. Method of measurement: The number of breaths a person takes per minute. Chest CT scan. Timepoint: Day 1 and day 14. Method of measurement: X ray imaging. High-sensitivity C-reactive protein. Timepoint: Day 1 and day 14. Method of measurement: Colorimetric method. Erythrocyte Sedimentation Rate. Timepoint: Day 1 and day 14. Method of measurement: Colorimetric method. Severity and number of coughs. Timepoint: Day 1 and day 14. Method of measurement: Cough visual analogue scale (VAS). Body temperature. Timepoint: Day 1 and day 14. Method of measurement: Clinical Thermometer. Alanine aminotransferase Activity. Timepoint: Day 1 and day 14. Method of measurement: Colorimetric method. Aspartate aminotransferase Activity. Timepoint: Day 1 and day 14. Method of measurement: Colorimetric method. Superoxide dismutase Activity. Timepoint: Day 1 and day 14. Method of measurement: Colorimetric method. Albumin. Timepoint: Day 1 and day 14. Method of measurement: Colorimetric method. Vice-Chancellor for Research, Esfahan University of Medical Sciences Approved 2020-07-29 Ethics committee of Isfahan University of Medical Sciences Hezarjarib Ave., Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)