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

Primary Purpose

SARS-CoV2 Infection

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

propolis

About this trial

This is an interventional supportive care trial for SARS-CoV2 Infection

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Trabzon Faculty of Medicine , Health Science University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

water extract of propolis

olive oil extract of propolis including perga

control

Arm Description

Patients given 2 ml of aqueous propolis extract (50mg / ml) orally 3 times a day for 1 week

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

control group (patients not given any investigational product)

Outcomes

Primary Outcome Measures

radiological

Lung tomography findings

laboratory parameters-2: ESR

ESR

laboratory parameters-3: CRP

CRP

laboratory parameters-4: D-Dimer

D-Dimer

laboratory parameters-5: Troponin

Troponin

laboratory parameters-6: sO2

sO2

laboratory parameters-1: CBC

CBC

Secondary Outcome Measures

Full Information

NCT ID

NCT04916821

First Posted

May 26, 2021

Last Updated

June 7, 2021

Sponsor

Trabzon Kanuni Education and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04916821

Brief Title

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

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 15, 2021 (Actual)

Primary Completion Date

July 15, 2021 (Anticipated)

Study Completion Date

August 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Trabzon Kanuni Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SARS-CoV2 Infection

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

water extract of propolis

Arm Type

Experimental

Arm Description

Patients given 2 ml of aqueous propolis extract (50mg / ml) orally 3 times a day for 1 week

Arm Title

olive oil extract of propolis including perga

Arm Type

Experimental

Arm Description

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

Arm Title

control

Arm Type

No Intervention

Arm Description

control group (patients not given any investigational product)

Intervention Type

Dietary Supplement

Intervention Name(s)

propolis

Intervention Description

Propolis may be blocked virus entry to cells, and some receptor binding and some cell signal molecules

Primary Outcome Measure Information:

Title

radiological

Description

Lung tomography findings

Time Frame

Change from Baseline Lung Tomography Findings(Peripheral ground-glass opacities) at one week

Title

laboratory parameters-2: ESR

Description

ESR

Time Frame

Change from Baseline ESR findings at one week

Title

laboratory parameters-3: CRP

Description

CRP

Time Frame

Change from Baseline CRP findings at one week

Title

laboratory parameters-4: D-Dimer

Description

D-Dimer

Time Frame

Change from Baseline D-Dimer findings at one week

Title

laboratory parameters-5: Troponin

Description

Troponin

Time Frame

Change from Baseline Troponin findings at one week

Title

laboratory parameters-6: sO2

Description

sO2

Time Frame

Change from Baseline sO2 findings at one week

Title

laboratory parameters-1: CBC

Description

CBC

Time Frame

Change from Baseline CBC findings at one week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Betül Değer Kulaksız, M.D

Organizational Affiliation

Trabzon Kanuni Education and Research Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Trabzon Faculty of Medicine , Health Science University

City

Trabzon

ZIP/Postal Code

61080

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Individual participant data will not be shared.

Citations:

PubMed Identifier

32890967

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.

Results Reference

background

PubMed Identifier

32945590

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.

Results Reference

background

Learn more about this trial

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

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