Investigation of Clinical Effectiveness of Propolis Extracts as Food Supplements in Patients With SARS-CoV-2(COVID-19)

Study Overview
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Brief Summary
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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.

Official Title
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Investigation of Clinical Effectiveness of Propolis Extracts as Food Supplements in Patients With SARS-CoV-2(COVID-19)

Conditions
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SARS-CoV2 Infection

Intervention / Treatment
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* Dietary Supplement: propolis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: water extract of propolis<br>Patients given 2 ml of aqueous propolis extract (50mg / ml) orally 3 times a day for 1 week | Dietary Supplement: propolis<br>* Propolis may be blocked virus entry to cells, and some receptor binding and some cell signal molecules<br>|
| Experimental: olive oil extract of propolis including perga<br>Patients given 1 ml oily propolis extract (64 mg / ml) + 1 ml oily perga extract (120 mg / ml) orally 3 times a day for 1 week | Dietary Supplement: propolis<br>* Propolis may be blocked virus entry to cells, and some receptor binding and some cell signal molecules<br>|
| No Intervention: control<br>control group (patients not given any investigational product) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiological | Lung tomography findings | Change from Baseline Lung Tomography Findings(Peripheral ground-glass opacities) at one week | 
| laboratory parameters-2: ESR | ESR | Change from Baseline ESR findings at one week | 
| laboratory parameters-3: CRP | CRP | Change from Baseline CRP findings at one week | 
| laboratory parameters-4: D-Dimer | D-Dimer | Change from Baseline D-Dimer findings at one week | 
| laboratory parameters-5: Troponin | Troponin | Change from Baseline Troponin findings at one week | 
| laboratory parameters-6: sO2 | sO2 | Change from Baseline sO2 findings at one week | 
| laboratory parameters-1: CBC | CBC | Change from Baseline CBC findings at one week |