Covid19NCT04680819
Evaluation of the Effect of Anatolian Propolis on Covid-19 in Healthcare Professionals
An observational study of Covid19, run by Ataturk University.
Trial summary
There is no prophylaxis for people at high risk of developing COVID-19. It is one of the first clinical studies aiming to investigate the effect of Anatolian Propolis against COVID-19. This study will test whether Anatolian propolis can be used to prevent the development of COVID-19 in people at risk of COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Anatolian Propolis
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 25 Dec 2020to 25 Jan 2021
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy emergency room workers who volunteer to participate in the research
Who may be able to join
- 18 years and over,
- Not having had COVID-19 (diagnosed by PCR)
- Symptom that may be associated with COVID-19 for the past 14 days (fever, fatigue, loss of taste and smell)
- No additional chronic disease (such as chronic heart lung)
- Healthcare workers (doctor, nurse, medical secretary)
- Working in an emergency medicine clinic
- Being a volunteer
Who cannot join
- Not being willing to participate in research
- Patients younger than 18 years old,
- Pregnant patients
- Immunosuppressive patients
- Patients receiving chemotherapy for any reason
- Being appointed to another clinic from the emergency medicine clinic within a 1-month period planned as a working period
- Propolis allergy or history of hypersensitivity to any of its ingredients.
- Volunteers taking a break from drug use during the study
Trial locations and contacts
No sites are listed yet.
About this study
There is no prophylaxis for people at high risk of developing COVID-19. It is one of the first clinical studies aiming to investigate the effect of Anatolian Propolis against COVID-19. This study will test whether Anatolian propolis can be used to prevent the development of COVID-19 in people at risk of COVID-19. If Anatolian Propolis has been shown to reduce the risk of developing COVID-19 in people at high risk of infection, this could help reduce the morbidity and mortality of the COVID-19 outbreak.
This study will be done in 2 centers. These centers are planned as Atatürk University Medical Faculty Emergency Medicine Clinic and Rize Recep Tayyip Erdoğan University Emergency Medicine Clinic. This work will be done entirely on a voluntary basis. The research subject will be explained to the healthcare professionals (doctor, nurse, medical secretary) working in both emergency medicine clinics and voluntary participation forms will be signed by the healthcare professionals who agree to participate in the study. Health workers who agree to participate in the study will be accepted as the study group, and healthcare professionals who do not agree to participate in the study will be accepted as the control group. The study group will be asked to take 20 drops of Propolis drop form twice a day in the morning / evening and the control group will not receive any treatment and both groups will be followed. In this process, patients diagnosed with COVID-19 will be determined.The study will cover a period of 1 month and at the end of 1 month, patients diagnosed with COVID-19 in the study and control groups will be compared. Thus, the protective properties of Anatolian propolis will be determined.
Read the detailed description
Severe Acute Respiratory Syndrome Coronavirus - 2 (SARS-CoV-2) caused by Covid-19 epidemics have been implicated in 330,000 more than cases in Turkey and 40 health workers at a rate close to 5% by thousand cases affected by this epidemic and There is a serious increase in risk for people every day.
There is currently no established post-exposure prophylaxis for people at high risk of developing COVID-19. Propolis, a natural resin produced by bees and of plant origin, has anti-inflammatory, immunomodulatory, anti-oxidant properties, and various aspects of the SARS-CoV-2 infection mechanism are potential targets for propolis compounds. This work; It is a randomized study aiming to evaluate the effect of Anatolian propolis extract against the effects of the new coronavirus threatening human health. In this clinical study, the product containing Anatolian propolis will be used to evaluate its effectiveness. According to the spectrophotometic analysis report of this product, there should be a minimum phenolic 106.0 mg gae per ml and 73.1 mg ke flavonoid content in each ml and a total content of 253.9 mg te / ml.
There is no prophylaxis for people at high risk of developing COVID-19. It is one of the first clinical studies aiming to investigate the effect of Anatolian Propolis against COVID-19. This study will test whether Anatolian propolis can be used to prevent the development of COVID-19 in people at risk of COVID-19. If Anatolian Propolis has been shown to reduce the risk of developing COVID-19 in people at high risk of infection, this could help reduce the morbidity and mortality of the COVID-19 outbreak.
This study will be done in 2 centers. These centers are planned as Atatürk University Medical Faculty Emergency Medicine Clinic and Rize Recep Tayyip Erdoğan University Emergency Medicine Clinic. This work will be done entirely on a voluntary basis. The research subject will be explained to the healthcare professionals (doctor, nurse, medical secretary) working in both emergency medicine clinics and voluntary participation forms will be signed by the healthcare professionals who agree to participate in the study. Health workers who agree to participate in the study will be accepted as the study group, and healthcare professionals who do not agree to participate in the study will be accepted as the control group. The study group will be asked to take 20 drops of Propolis drop form twice a day in the morning / evening and the control group will not receive any treatment and both groups will be followed. In this process, patients diagnosed with COVID-19 will be determined.
For the diagnosis of COVID-19, PCR test positivity taken from the throat will be accepted. The study will cover a period of 1 month and at the end of 1 month, patients diagnosed with COVID-19 in the study and control groups will be compared. Thus, the protective properties of Anatolian propolis will be determined.
The data obtained will be analyzed with the SPSS.20 program. Data will be given as percentages and numbers. Shapiro-Wilk and Kolmogorov-Smirnov tests will be used to evaluate whether the data are suitable for normal distribution. Independent samples t-test will be used to compare data normally distributed between two independent groups, and the Mann-Whitney U test will be used if the data are not normally distributed. Categorical variables will be compared using Chi-square and Fisher tests. A value of p <0.05 will be considered statistically significant.
- Conditions
- Covid19
- Being tested
- Anatolian Propolis
- Keywords
- covid-19, Anatolian Propolis
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatolian PropolisDietary supplement
Health workers who agree to participate in the study will be accepted as the study group, and healthcare professionals who do not agree to participate in the study will be considered as the control group. The study group will be asked to take 20 drops of Propolis drop form twice a day in the morning / evening, and the control group will not receive any treatment and both groups will be followed. In this process, patients diagnosed with COVID-19 will be determined. PCR test positivity taken from the throat for the diagnosis of COVID-19 will be accepted. The research will cover a period of 1 month. At the end of 1 month, patients diagnosed with COVID-19 in the study and control groups will be compared. Thus, the protective properties of Anatolian propolis will be determined.
| Study group | Role | What they receive |
|---|---|---|
| Compared with given anatolian propolis group and do not use anatolian propolis group | According to the spectrophotometic analysis report of this anatolian group, there should be a minimum phenolic 106.0 mg gae per ml and 73.1 mg ke flavonoid content in each ml and a total content of 253.9 mg te / ml. Receives: Dietary Supplement: Anatolian Propolis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Covid-19 positive
For the diagnosis of COVID-19, the positivity of the PCR test taken from the throat will be investigated.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start25 Dec 2020 (estimated)
- Primary completion25 Jan 2021 (estimated)
- Study completion25 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Osman KOCAK, Ataturk University
- Investigators
- Ataturk University Osman, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680819
- Sponsor's protocol ID
- AtaturkU2
- Status last verified
- Dec 2020
- First submitted
- 19 Dec 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: will be shared as soon as appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Anatolian Propolis on Covid-19 in Healthcare Professionals
- ClinicalTrials.gov ID
- NCT04680819
- Acronym / sponsor ID
- AtaturkU2
- Conditions
- Covid19
- Keywords
- covid-19, Anatolian Propolis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 25 Dec 2020 (estimated)
- Primary completion
- 25 Jan 2021 (estimated)
- Study completion
- 25 Jan 2021 (estimated)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is no prophylaxis for people at high risk of developing COVID-19. It is one of the first clinical studies aiming to investigate the effect of Anatolian Propolis against COVID-19. This study will test whether Anatolian propolis can be used to prevent the development of COVID-19 in people at risk of COVID-19. If Anatolian Propolis has been shown to reduce the risk of developing COVID-19 in people at high risk of infection, this could help reduce the morbidity and mortality of the COVID-19 outbreak.
This study will be done in 2 centers. These centers are planned as Atatürk University Medical Faculty Emergency Medicine Clinic and Rize Recep Tayyip Erdoğan University Emergency Medicine Clinic. This work will be done entirely on a voluntary basis. The research subject will be explained to the healthcare professionals (doctor, nurse, medical secretary) working in both emergency medicine clinics and voluntary participation forms will be signed by the healthcare professionals who agree to participate in the study. Health workers who agree to participate in the study will be accepted as the study group, and healthcare professionals who do not agree to participate in the study will be accepted as the control group. The study group will be asked to take 20 drops of Propolis drop form twice a day in the morning / evening and the control group will not receive any treatment and both groups will be followed. In this process, patients diagnosed with COVID-19 will be determined.The study will cover a period of 1 month and at the end of 1 month, patients diagnosed with COVID-19 in the study and control groups will be compared. Thus, the protective properties of Anatolian propolis will be determined.
Detailed description
Severe Acute Respiratory Syndrome Coronavirus - 2 (SARS-CoV-2) caused by Covid-19 epidemics have been implicated in 330,000 more than cases in Turkey and 40 health workers at a rate close to 5% by thousand cases affected by this epidemic and There is a serious increase in risk for people every day.
There is currently no established post-exposure prophylaxis for people at high risk of developing COVID-19. Propolis, a natural resin produced by bees and of plant origin, has anti-inflammatory, immunomodulatory, anti-oxidant properties, and various aspects of the SARS-CoV-2 infection mechanism are potential targets for propolis compounds. This work; It is a randomized study aiming to evaluate the effect of Anatolian propolis extract against the effects of the new coronavirus threatening human health. In this clinical study, the product containing Anatolian propolis will be used to evaluate its effectiveness. According to the spectrophotometic analysis report of this product, there should be a minimum phenolic 106.0 mg gae per ml and 73.1 mg ke flavonoid content in each ml and a total content of 253.9 mg te / ml.
There is no prophylaxis for people at high risk of developing COVID-19. It is one of the first clinical studies aiming to investigate the effect of Anatolian Propolis against COVID-19. This study will test whether Anatolian propolis can be used to prevent the development of COVID-19 in people at risk of COVID-19. If Anatolian Propolis has been shown to reduce the risk of developing COVID-19 in people at high risk of infection, this could help reduce the morbidity and mortality of the COVID-19 outbreak.
This study will be done in 2 centers. These centers are planned as Atatürk University Medical Faculty Emergency Medicine Clinic and Rize Recep Tayyip Erdoğan University Emergency Medicine Clinic. This work will be done entirely on a voluntary basis. The research subject will be explained to the healthcare professionals (doctor, nurse, medical secretary) working in both emergency medicine clinics and voluntary participation forms will be signed by the healthcare professionals who agree to participate in the study. Health workers who agree to participate in the study will be accepted as the study group, and healthcare professionals who do not agree to participate in the study will be accepted as the control group. The study group will be asked to take 20 drops of Propolis drop form twice a day in the morning / evening and the control group will not receive any treatment and both groups will be followed. In this process, patients diagnosed with COVID-19 will be determined.
For the diagnosis of COVID-19, PCR test positivity taken from the throat will be accepted. The study will cover a period of 1 month and at the end of 1 month, patients diagnosed with COVID-19 in the study and control groups will be compared. Thus, the protective properties of Anatolian propolis will be determined.
The data obtained will be analyzed with the SPSS.20 program. Data will be given as percentages and numbers. Shapiro-Wilk and Kolmogorov-Smirnov tests will be used to evaluate whether the data are suitable for normal distribution. Independent samples t-test will be used to compare data normally distributed between two independent groups, and the Mann-Whitney U test will be used if the data are not normally distributed. Categorical variables will be compared using Chi-square and Fisher tests. A value of p <0.05 will be considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compared with given anatolian propolis group and do not use anatolian propolis group | – | Dietary Supplement: Anatolian PropolisAccording to the spectrophotometic analysis report of this anatolian group, there should be a minimum phenolic 106.0 mg gae per ml and 73.1 mg ke flavonoid content in each ml and a total content of 253.9 mg te / ml. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy emergency room workers who volunteer to participate in the research
Key inclusion criteria (7 listed)
- 18 years and over,
- Not having had COVID-19 (diagnosed by PCR)
- Symptom that may be associated with COVID-19 for the past 14 days (fever, fatigue, loss of taste and smell)
- No additional chronic disease (such as chronic heart lung)
- Healthcare workers (doctor, nurse, medical secretary)
Key exclusion criteria (8 listed)
- Not being willing to participate in research
- Patients younger than 18 years old,
- Pregnant patients
- Immunosuppressive patients
- Patients receiving chemotherapy for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anatolian PropolisHealth workers who agree to participate in the study will be accepted as the study group, and healthcare professionals who do not agree to participate in the study will be considered as the control group. The study group will be asked to take 20 drops of Propolis drop form twice a day in the morning / evening, and the control group will not receive any treatment and both groups will be followed. In this process, patients diagnosed with COVID-19 will be determined. PCR test positivity taken from the throat for the diagnosis of COVID-19 will be accepted. The research will cover a period of 1 month. At the end of 1 month, patients diagnosed with COVID-19 in the study and control groups will be compared. Thus, the protective properties of Anatolian propolis will be determined. | Dietary supplement | Compared with given anatolian propolis group and do not use anatolian propolis group |
Primary outcome
Covid-19 positive
Time frame: 1 month
For the diagnosis of COVID-19, the positivity of the PCR test taken from the throat will be investigated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Individual participant dataSharing planned: Yes. will be shared as soon as appropriate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ataturk University Osman principal investigator
Ataturk University
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Ataturk University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdullah Osman KOCAK (+905445667158, abdullahmrym86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Covid-19 positive (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020; AzTrials last refreshed its copy on 8 Nov 2026.