The Effect of Honey on Nocturnal Cough and Sleep Quality

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575821
• Other study ID #: hermanhoney
• Status: Completed
• Phase: N/A
• First received: April 8, 2012
• Last updated: April 11, 2012
• Start date: January 2009
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 5 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cough
• Sleep

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Israel	6 General Pediatric Community Clinics	Petach-Tikva

Sponsors (2)

Lead Sponsor	Collaborator
Meir Medical Center	Ambulatory Pediatric Association

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	changes between two nights ( the night before treatment and the night with treatment)	No
Secondary	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".	changes between two nights ( the night before treatment and the night with treatment)	No