The Effect of Honey on Nocturnal Cough and Sleep Quality

Not Applicable

Completed

• Conditions: Cough; Sleep
• Interventions: Dietary Supplement: Eucalyptus honey; Dietary Supplement: Labiatae honey; Dietary Supplement: Silan date extract; Dietary Supplement: Citrus honey

• Registration Number: NCT01575821
• Lead Sponsor: Meir Medical Center

Brief Summary

Cough is a common symptom in pediatric practice. It can be particularly troubling to children and their parents.It often results in discomfort to the child and loss of sleep to both the child and the parent. The objective of this trial was to compare the effects on nocturnal cough and the sleep difficulty associated with URIs of a single nocturnal dose of three different honey products compared to placebo

Detailed Description

Cough is a common symptom in pediatric practice.As a result, children miss daycare or school and parents miss a day of work. In an attempt to threat cough, caregivers frequently administer OTC medication to their children,with their attendant risks, kack of proven efficacy and the disapproval of professional organizations such as the AAP and the FDA. The WHO has noted honey as a potential treatment for cough and cold symptoms. Honey has antioxidant properties and increases cytokine release. The objective of this trial was to compare the effects on nocturnal cough and the sleep difficulty associated with URIs of a single nocturnal dose of three different honey products compared to placebo

Study Timeline

• Study Start: 2009-01
• Status Verified: 2012-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Study First Submitted: 2012-04-08
• Study First Submitted QC: 2012-04-11
• Last Update Submitted: 2012-04-11
• Study First Posted: 2012-04-12
• Last Update Posted: 2012-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 1-5 years of age complying of nocturnal cough that was attributed to a URI.

Exclusion Criteria

• asthma,
• pneumonia,
• laryngotracheobronchitis,
• sinusitis,
• allergic rhinitis,
• use of cough or cold medication on the night before entering the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eucalyptus honey ,	Eucalyptus honey	75 children
Labiatae honey	Labiatae honey	75 children allocated
Silan date extract (placebo)	Silan date extract	75 children allocated
Citrus honey	Citrus honey	75 children allocated

Primary Outcome Measures

Name	Time	Method
The principal outcome measure of interest was the change in the frequency of cough between the 2 nights (before treatment and tthe night with treatment).	changes between two nights ( the night before treatment and the night with treatment)	Pre intervention study questionnaire: The parents were asked to complete a five item questionnaire regarding parental subjective assessments of the child's cough and sleep difficulty on the previous night.Survey responses were graded on a seven point scale ranging from extremely (6 points) to not at all (0 points). On the day following the treatment,the parent completed the same questionnaire that had been answered before the intervention, this time regarding the previous evening when the child had received the treatment.

Secondary Outcome Measures

Name	Time	Method
changes in the cough severity, the bothersome nature of the cough, the effect of the cough on sleep for both the child and parents between the two nights	changes between two nights ( the night before treatment and the night with treatment)	Assessment was been done by completing the pre and post intervention questionnaire as was described in the " primary outcome measurment".

Trial Locations

Locations (1)

6 General Pediatric Community Clinics; 🇮🇱 Petach-Tikva, Israel