Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06455007
Status:
COMPLETED
Last Update Posted:
2024-06-12
First Post:
2024-05-31
Brief Title:
Propolis as a Treatment Option for Hand Foot and Mouth Disease
Sponsor:
Murat Sutcu
Organization:
Eskisehir Osmangazi University
Study Overview
Official Title:
Propolis as a Treatment Option for Hand Foot and Mouth Disease
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childs 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
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 childs 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None