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

NCT04916821 | Unknown

• 1 other identifier: 00001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV2 Infection

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (3)

water extract of propolis

EXPERIMENTAL

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

Dietary Supplement: propolis

olive oil extract of propolis including perga

EXPERIMENTAL

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

control

NO INTERVENTION

control group (patients not given any investigational product)

Interventions

propolis 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; water extract of propolis

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• patients do not have oral intake
• patients whose informed consent form is not approved
• patients who need a ventilator
• pregnant women
• children

Sponsors & Collaborators

• Trabzon Kanuni Education and Research Hospital: lead

Study Sites (1)

Trabzon Faculty of Medicine , Health Science University

Trabzon, 61080, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 32890967 BACKGROUND

• 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.

  PMID: 32945590 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Propolis

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Study Officials

• Betül Değer Kulaksız, M.D

  Trabzon Kanuni Education and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: 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

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 8, 2021
• Study Start: May 15, 2021
• Primary Completion: July 15, 2021
• Study Completion: August 15, 2021
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)