The Effect of Honey on Nocturnal Cough and Sleep Quality

Sponsor

Meir Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01575821

Collaborator

Ambulatory Pediatric Association (Other)

300

Enrollment

Location

Arms

Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cough Sleep	Dietary Supplement: Eucalyptus honey Dietary Supplement: Labiatae honey Dietary Supplement: Citrus honey Dietary Supplement: Silan date extract	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Supportive Care

Official Title:

The Effect of Honey on Nocturnal Cough and Sleep Quality: a Double-blind, Randomized,Placebo-controlled Study

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eucalyptus honey , 75 children	Dietary Supplement: Eucalyptus honey Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.
Experimental: Labiatae honey 75 children allocated	Dietary Supplement: Labiatae honey Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.
Experimental: Silan date extract (placebo) 75 children allocated	Dietary Supplement: Silan date extract Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.
Experimental: Citrus honey 75 children allocated	Dietary Supplement: Citrus honey Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.

Outcome Measures

Primary Outcome Measures

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

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".

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	6 General Pediatric Community Clinics	Petach-Tikva		Israel	56000

Sponsors and Collaborators

Meir Medical Center
Ambulatory Pediatric Association

Investigators

Principal Investigator: Cohen AV Herman, Israel Clalit Health Services

Study Documents (Full-Text)

None provided.

More Information

Publications

Paul IM, Beiler J, McMonagle A, Shaffer ML, Duda L, Berlin CM Jr. Effect of honey, dextromethorphan, and no treatment on nocturnal cough and sleep quality for coughing children and their parents. Arch Pediatr Adolesc Med. 2007 Dec;161(12):1140-6.

Responsible Party:

Meir Medical Center

ClinicalTrials.gov Identifier:

NCT01575821

Other Study ID Numbers:

hermanhoney

First Posted:

Apr 12, 2012

Last Update Posted:

Apr 12, 2012

Last Verified:

Apr 1, 2012

Keywords provided by Meir Medical Center

children, cough, honey

Additional relevant MeSH terms:

Cough

Study Results

No Results Posted as of Apr 12, 2012