The effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19): A structured summar
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The effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19): A structured summary of a study protocol for a randomised controlled trial Mahsa Miryan1,2, Davood Soleimani3, Leila Dehghani4, Karim Sohrabi5, Farzin Khorvash6, Mohammad Bagherniya7,8,9, Sayed Mazaher Sayedi10 and Gholamreza Askari7,8,9*
Abstract Objectives: This study aims to assess the effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19). Trial design: This is a Double-Blind, Placebo-Controlled, Parallel Arm, Randomized Phase ΙΙ Clinical Trial. Participants: Patients with the confirmed COVID-19 based on the PCR test are eligible to participate in the trial if they are 18 to 75 years of age and have no history of the current use of warfarin or propolis supplement and presence of sensitivity to bee products. Patients will be recruited from the Al-Zahra hospital in Isfahan city, Isfahan, Iran. Intervention and comparator: Participants (N=40) in the intervention group will receive an identical propolis tablet (containing 300 mg Iranian green propolis extract) three times a day for a period of 2 weeks. Participants (N=40) in the control group will receive an identical placebo tablet (containing 300 mg microcrystalline cellulose) three times a day for 2 weeks. All tablets are prepared by the Reyhan Naghsh Jahan Pharmaceutical Co., Isfahan, Iran. Main outcomes: The main outcomes are changes in the coronavirus disease’s clinical symptoms including duration and severity from baseline to the end of 2 weeks. Randomization: Eligible patients will be randomly allocated in a 1:1 ratio to the intervention or control group. Randomization will be performed on the basis of permuted block sizes of 4 and will be stratified according to sex categories. Randomization sequences will be prepared by the trial’s pharmacist with the use of random-number tables. (Continued on next page)
* Correspondence: [email protected]; [email protected] 7 Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran 8 Anesthesia and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan, Iran Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view
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