The Effect of Honey on Nocturnal Cough and Sleep Quality
Primary Purpose
Cough, Sleep
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Eucalyptus honey
Labiatae honey
Citrus honey
Silan date extract
Sponsored by
About this trial
This is an interventional supportive care trial for Cough focused on measuring children, cough, honey
Eligibility Criteria
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.
Sites / Locations
- 6 General Pediatric Community Clinics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Eucalyptus honey ,
Labiatae honey
Silan date extract (placebo)
Citrus honey
Arm Description
75 children
75 children allocated
75 children allocated
75 children allocated
Outcomes
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).
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
Assessment was been done by completing the pre and post intervention questionnaire as was described in the " primary outcome measurment".
Full Information
NCT ID
NCT01575821
First Posted
April 8, 2012
Last Updated
April 11, 2012
Sponsor
Meir Medical Center
Collaborators
Ambulatory Pediatric Association
1. Study Identification
Unique Protocol Identification Number
NCT01575821
Brief Title
The Effect of Honey on Nocturnal Cough and Sleep Quality
Official Title
The Effect of Honey on Nocturnal Cough and Sleep Quality: a Double-blind, Randomized,Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
Collaborators
Ambulatory Pediatric Association
4. Oversight
Data Monitoring Committee
No
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough, Sleep
Keywords
children, cough, honey
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eucalyptus honey ,
Arm Type
Experimental
Arm Description
75 children
Arm Title
Labiatae honey
Arm Type
Experimental
Arm Description
75 children allocated
Arm Title
Silan date extract (placebo)
Arm Type
Experimental
Arm Description
75 children allocated
Arm Title
Citrus honey
Arm Type
Experimental
Arm Description
75 children allocated
Intervention Type
Dietary Supplement
Intervention Name(s)
Eucalyptus honey
Intervention Description
Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.
Intervention Type
Dietary Supplement
Intervention Name(s)
Labiatae honey
Intervention Description
Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.
Intervention Type
Dietary Supplement
Intervention Name(s)
Citrus honey
Intervention Description
Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.
Intervention Type
Dietary Supplement
Intervention Name(s)
Silan date extract
Intervention Description
Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
changes between two nights ( the night before treatment and the night with treatment)
Secondary Outcome Measure Information:
Title
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
Description
Assessment was been done by completing the pre and post intervention questionnaire as was described in the " primary outcome measurment".
Time Frame
changes between two nights ( the night before treatment and the night with treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cohen AV Herman
Organizational Affiliation
Israel Clalit Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
6 General Pediatric Community Clinics
City
Petach-Tikva
ZIP/Postal Code
56000
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
18056558
Citation
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. doi: 10.1001/archpedi.161.12.1140.
Results Reference
background
PubMed Identifier
22869830
Citation
Cohen HA, Rozen J, Kristal H, Laks Y, Berkovitch M, Uziel Y, Kozer E, Pomeranz A, Efrat H. Effect of honey on nocturnal cough and sleep quality: a double-blind, randomized, placebo-controlled study. Pediatrics. 2012 Sep;130(3):465-71. doi: 10.1542/peds.2011-3075. Epub 2012 Aug 6.
Results Reference
derived
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The Effect of Honey on Nocturnal Cough and Sleep Quality
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