Propolis as a Treatment Option for Hand Foot and Mouth Disease

NCT06455007 | Completed Phase 2 DMC

• 1 other identifier: HMFD-24
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Children Diagnosed With HMFD; Propolis Antiviral Activity

Keywords

HMFD; children; Propolis

Outcome Measures

Primary Outcomes (1)

• 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.

  48 hours and 7 days

Study Arms (2)

Propolis group

EXPERIMENTAL

. Propolis 3x10 drops (7 days) were used in the propolis group.

Drug: Propolis

Control group

NO INTERVENTION

Interventions

Propolis DRUG

Propolis 3x10 drops (7 days)

Propolis group

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients diagnosed with HMFD
• years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Murat Sutcu: lead

Study Sites (1)

Istinye University Medicine Faculty Hospital

Esenyurt, Istanbul, 34517, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Propolis

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients in both groups were prescribed antipyretics and antihistamines when deemed appropriate by the clinician. Propolis 3x10 drops (7 days) were used in the propolis group. Both the investigators and the patients were aware of the drug being given. A computerized randomization program was used for group selection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: control and treatment group

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 12, 2024
• Study Start: January 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: June 12, 2024

Record last verified: 2024-06

Locations

TU (1)