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

June 7, 2021 updated by: Betül Değer Kulaksız, Trabzon Kanuni Education and Research Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Trabzon, Turkey, 61080
        • Trabzon Faculty of Medicine , Health Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: water extract of propolis
Patients given 2 ml of aqueous propolis extract (50mg / ml) orally 3 times a day for 1 week
Dietary supplement: propolis
Propolis may be blocked virus entry to cells, and some receptor binding and some cell signal molecules
EXPERIMENTAL: olive oil extract of propolis including perga
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
Propolis may be blocked virus entry to cells, and some receptor binding and some cell signal molecules
NO_INTERVENTION: control
control group (patients not given any investigational product)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trabzon Kanuni Education and Research Hospital

Investigators

  • Study Chair: Betül Değer Kulaksız, M.D, Trabzon Kanuni Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2021

Primary Completion (ANTICIPATED)

July 15, 2021

Study Completion (ANTICIPATED)

August 15, 2021

Study Registration Dates

First Submitted

May 26, 2021

First Submitted That Met QC Criteria

June 7, 2021

First Posted (ACTUAL)

June 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 8, 2021

Last Update Submitted That Met QC Criteria

June 7, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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