Clinical trial NCT04916821: Investigation of Clinical Effectiveness of Propolis Extracts as Food Supplements in Patients With SARS-CoV-2(COVID-19)
Official title: Investigation of Clinical Effectiveness of Propolis Extracts as Food Supplements in Patients With SARS-CoV-2(COVID-19)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: SARS-CoV2 Infection
Lead sponsor: Trabzon Kanuni Education and Research Hospital
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: first group treated with water extracts of propolis second group treated with olive oil extracts of propolis including perga third group treated with no bee product
Primary purpose: SUPPORTIVE_CARE

Brief summary: Primary purpose: To investigate the effect of propolis, a food supplement product, on healing parameters in patients with COVID 19. Secondary purpose: To provide a new supportive treatment in Covid 19 treatment. In the present study to examine the effect of the use of propolis on healing parameters (laboratory and imaging) in patients with COVID 19; Propolis, which has antiviral properties, has also been used in humans in the COVID19 pandemic as of 2020. However, in these studies, an alcohol-soluble extract of propolis was used. Despite the disadvantages of its use in alcohol, it is clear that water and olive oil extracts of Propolis are safer for humans. Therefore, water extracts of propolis will be used in the study.


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 who do not need a ventilator who are inpatient in the Covid service
* Patients under the age of 60 who do not need a ventilator who are inpatient in the Covid service

Exclusion Criteria:

* patients do not have oral intake
* patients whose informed consent form is not approved
* patients who need a ventilator
* pregnant women
* children

Primary outcomes:
measure: radiological
timeFrame: Change from Baseline Lung Tomography Findings(Peripheral ground-glass opacities) at one week
measure: laboratory parameters-2: ESR
timeFrame: Change from Baseline ESR findings at one week
measure: laboratory parameters-3: CRP
timeFrame: Change from Baseline CRP findings at one week
measure: laboratory parameters-4: D-Dimer
timeFrame: Change from Baseline D-Dimer findings at one week
measure: laboratory parameters-5: Troponin
timeFrame: Change from Baseline Troponin findings at one week
measure: laboratory parameters-6: sO2
timeFrame: Change from Baseline sO2 findings at one week
measure: laboratory parameters-1: CBC
timeFrame: Change from Baseline CBC findings at one week
Secondary outcomes:
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Trabzon Faculty of Medicine , Health Science University
Study officials:
affiliation: Trabzon Kanuni Education and Research Hospital
name: Betül Değer Kulaksız, M.D
role: STUDY_CHAIR
References:
citation: Berretta AA, Silveira MAD, Condor Capcha JM, De Jong D. Propolis and its potential against SARS-CoV-2 infection mechanisms and COVID-19 disease: Running title: Propolis against SARS-CoV-2 infection and COVID-19. Biomed Pharmacother. 2020 Nov;131:110622. doi: 10.1016/j.biopha.2020.110622. Epub 2020 Aug 17.
citation: Lima WG, Brito JCM, da Cruz Nizer WS. Bee products as a source of promising therapeutic and chemoprophylaxis strategies against COVID-19 (SARS-CoV-2). Phytother Res. 2021 Feb;35(2):743-750. doi: 10.1002/ptr.6872. Epub 2020 Sep 18.