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

NCT ID: NCT04916821

Last Updated: 2021-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-15

Study Completion Date

2021-08-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

SARS-CoV2 Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

water extract of propolis

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

Group Type EXPERIMENTAL

propolis

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type EXPERIMENTAL

propolis

Intervention Type DIETARY_SUPPLEMENT

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

control

control group (patients not given any investigational product)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

propolis

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Trabzon Kanuni Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Betül Değer Kulaksız

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Betül Değer Kulaksız, M.D

Role: STUDY_CHAIR

Trabzon Kanuni Education and Research Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Trabzon Faculty of Medicine , Health Science University

Trabzon, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 32890967 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32945590 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

00001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nigella Sativa in COVID-19
NCT04401202 COMPLETED PHASE2