Children Diagnosed With HMFDPhase 2/3NCT06455007
Propolis as a Treatment Option for Hand Foot and Mouth Disease
A Phase 2/3 study testing Propolis in people with Children Diagnosed With HMFD and Propolis Antiviral Activity, run by Murat Sutcu at 1 site in Turkey (Türkiye).
Trial summary
Hand foot and mouth disease (HFMD) is a frequently self-limited viral infectious disease in children with no specific antiviral treatment option. There has been an increasing interest in bee products in recent years, and propolis has come to the fore with its high therapeutic and protective effect. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Children Diagnosed With HMFD, Propolis Antiviral Activity
- What is being tested?
- Propolis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Jan 2023
- Phase
- Phase 2/3
- 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients diagnosed with HMFD
- 1-10 years old
Who cannot join
- The patients whose complaints were longer than 48 hours,
- those whose parents stated that they could not comply with the follow ups,
- those who were taking another antiviral or supportive treatment,
- those who had used antibiotics in the last 1 month,
- those with a history of immunodeficiency or a family history of immunodeficiency,
- those who had a history of anaphylaxis with any support product or drug,
- patients with a chronic disease or skin lesion
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istinye University Medicine Faculty Hospital
Esenyurt, Istanbul, 34517
About this study
Hand foot and mouth disease (HFMD) is a frequently self-limited viral infectious disease in children with no specific antiviral treatment option. There has been an increasing interest in bee products in recent years, and propolis has come to the fore with its high therapeutic and protective effect. Although the inhibitory effect of propolis against enteroviruses (EVs) has been shown in studies, there is no clinical data regarding its use in the course of HFMD.
The aim of this prospective multicenter randomized clinical study was to evaluate the effect of propolis use in children with HFMD. The patients were randomly assigned to have Anatolian propolis or no supplement - control group in addition to symptomatic therapy decided by the physician. The duration of the patients' complaints, the distribution of the lesions in the body, and the fever status were recorded on admission. Parents were asked to rate the severity of the child's restlessness, inappetence, and sleeplessness status on a scale of 0-10 on the initial, 2nd (at 48th hour), and 3rd (on 5-7 days) visits.
Read the detailed description
Title of the Research Project / Thesis: "Evaluation of the effectiveness of Propolis in children with hand, foot and mouth disease"
INTRODUCTION AND PURPOSE Hand, foot and mouth disease is a highly contagious viral disease, especially in children under 10 years of age. Rarely, the disease can also be seen in older children and adults. It is a clinical picture characterized by fever, sore throat, loss of appetite, weakness, and rashes in and around the mouth, palms and soles of the feet. Rashes can be in the form of red, round lesions, or sometimes they can be seen in the form of fluid-filled vesicles. Hand, foot and mouth disease is mostly a self-limiting viral disease that does not cause severe disease. Patients recover completely within 7 to 10 days with the disappearance of all developing findings. As a very rare complication, it can cause viral or aseptic meningitis.
The patients were planned to be divided into two groups by randomization, the propolis group and the placebo group. Fever, sore throat, loss of appetite, weakness, rash and other complaints of the patients will be recorded at the time of admission and treatment will be started according to the randomization group. The patient will be given a family follow-up form and will be asked to follow up the complaints. At the 48th and 72nd hours of the follow-up, the patient was scheduled to be called for the first follow-up in terms of complaints and undesirable effects. The second and final follow-up was planned to be done on the 10th day and the patient follow-up was terminated as a family follow-up card. The number of patients targeted to be reached was determined as 100 for each group. The study period is foreseen as a total of 12 months, including 6 months for the collection of samples and data, 6 months for statistical analysis, evaluation of the results and writing them as an article. Statistical evaluation of the findings will be made with a statistical package program.
DOSES; Propolis 3x5 drops
- Being tested
- Propolis
- Keywords
- HMFD, children, Propolis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropolisDrug
Propolis 3x10 drops (7 days)
| Study group | Role | What they receive |
|---|---|---|
| Propolis group | Experimental | . Propolis 3x10 drops (7 days) were used in the propolis group. Receives: Drug: Propolis |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propolis treatment
Parents were asked to rate the severity of the child's restlessness, inappetence, and sleeplessness status on a scale of 0-10. The patients' fever status, restlessness, inappetence, and sleeplessness scores were asked again to their parents and recorded. total duration of the disease and the duration of restlessness, inappetence, and sleeplessness were recorded.
Measured: 48 hours and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Jan 2019
- Primary completion1 Jan 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children Diagnosed With HMFDStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- control and treatment group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murat Sutcu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Murat Sutcu, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455007
- Sponsor's protocol ID
- HMFD-24
- Status last verified
- Jun 2024
- First submitted
- 31 May 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Yes, ıt will be shared after publication.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propolis as a Treatment Option for Hand Foot and Mouth Disease
- ClinicalTrials.gov ID
- NCT06455007
- Acronym / sponsor ID
- HMFD-24
- Keywords
- HMFD, children, Propolis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Murat SutcuUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 12 Jun 2024 (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.
Hand foot and mouth disease (HFMD) is a frequently self-limited viral infectious disease in children with no specific antiviral treatment option. There has been an increasing interest in bee products in recent years, and propolis has come to the fore with its high therapeutic and protective effect. Although the inhibitory effect of propolis against enteroviruses (EVs) has been shown in studies, there is no clinical data regarding its use in the course of HFMD.
The aim of this prospective multicenter randomized clinical study was to evaluate the effect of propolis use in children with HFMD. The patients were randomly assigned to have Anatolian propolis or no supplement - control group in addition to symptomatic therapy decided by the physician. The duration of the patients' complaints, the distribution of the lesions in the body, and the fever status were recorded on admission. Parents were asked to rate the severity of the child's restlessness, inappetence, and sleeplessness status on a scale of 0-10 on the initial, 2nd (at 48th hour), and 3rd (on 5-7 days) visits.
Detailed description
Title of the Research Project / Thesis: "Evaluation of the effectiveness of Propolis in children with hand, foot and mouth disease"
INTRODUCTION AND PURPOSE Hand, foot and mouth disease is a highly contagious viral disease, especially in children under 10 years of age. Rarely, the disease can also be seen in older children and adults. It is a clinical picture characterized by fever, sore throat, loss of appetite, weakness, and rashes in and around the mouth, palms and soles of the feet. Rashes can be in the form of red, round lesions, or sometimes they can be seen in the form of fluid-filled vesicles. Hand, foot and mouth disease is mostly a self-limiting viral disease that does not cause severe disease. Patients recover completely within 7 to 10 days with the disappearance of all developing findings. As a very rare complication, it can cause viral or aseptic meningitis.
The patients were planned to be divided into two groups by randomization, the propolis group and the placebo group. Fever, sore throat, loss of appetite, weakness, rash and other complaints of the patients will be recorded at the time of admission and treatment will be started according to the randomization group. The patient will be given a family follow-up form and will be asked to follow up the complaints. At the 48th and 72nd hours of the follow-up, the patient was scheduled to be called for the first follow-up in terms of complaints and undesirable effects. The second and final follow-up was planned to be done on the 10th day and the patient follow-up was terminated as a family follow-up card. The number of patients targeted to be reached was determined as 100 for each group. The study period is foreseen as a total of 12 months, including 6 months for the collection of samples and data, 6 months for statistical analysis, evaluation of the results and writing them as an article. Statistical evaluation of the findings will be made with a statistical package program.
DOSES; Propolis 3x5 drops
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- control and treatment group
| Arm | Type | Receives |
|---|---|---|
| Propolis group | Experimental | Drug: Propolis. Propolis 3x10 drops (7 days) were used in the propolis group. |
| Control group | No intervention | – |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients diagnosed with HMFD
- 1-10 years old
Key exclusion criteria (7 listed)
- The patients whose complaints were longer than 48 hours,
- those whose parents stated that they could not comply with the follow ups,
- those who were taking another antiviral or supportive treatment,
- those who had used antibiotics in the last 1 month,
- those with a history of immunodeficiency or a family history of immunodeficiency,
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 |
|---|---|---|
| PropolisPropolis 3x10 drops (7 days) | Drug | Propolis group |
Primary outcome
Propolis treatment
Time frame: 48 hours and 7 days
Parents were asked to rate the severity of the child's restlessness, inappetence, and sleeplessness status on a scale of 0-10. The patients' fever status, restlessness, inappetence, and sleeplessness scores were asked again to their parents and recorded. total duration of the disease and the duration of restlessness, inappetence, and sleeplessness were recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: Undecided. Yes, ıt will be shared after publication.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Propolis in people with Children Diagnosed With HMFD and Propolis Antiviral Activity, run by Murat Sutcu at 1 site in Turkey (Türkiye).
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propolis treatment (time frame: 48 hours and 7 days). 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 12 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.