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

SARS-CoV2 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04916821
• Other study ID #: 00001
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 15, 2021
• Est. completion date: August 15, 2021

Study information

• Verified date: June 2021
• Source: Trabzon Kanuni Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: August 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• SARS-CoV2 Infection

Intervention

Dietary Supplement:
• propolis
Propolis may be blocked virus entry to cells, and some receptor binding and some cell signal molecules

Locations

Country	Name	City	State
Turkey	Trabzon Faculty of Medicine , Health Science University	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Trabzon Kanuni Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Berretta AA, Silveira MAD, Cóndor 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. Review. — View 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. Review. — View Citation

Outcome

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