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The Effect of Honey on Nocturnal Cough and Sleep Quality

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01575821
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : April 12, 2012
Sponsor:
Collaborator:
Ambulatory Pediatric Association
Information provided by (Responsible Party):
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

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 Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
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 : January 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

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.




Primary Outcome Measures :
  1. 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). [ Time Frame: 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 :
  1. 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 [ Time Frame: 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".



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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575821


Locations
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Israel
6 General Pediatric Community Clinics
Petach-Tikva, Israel, 56000
Sponsors and Collaborators
Meir Medical Center
Ambulatory Pediatric Association
Investigators
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Principal Investigator: Cohen AV Herman Israel Clalit Health Services
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01575821    
Other Study ID Numbers: hermanhoney
First Posted: April 12, 2012    Key Record Dates
Last Update Posted: April 12, 2012
Last Verified: April 2012
Keywords provided by Meir Medical Center:
children, cough, honey
Additional relevant MeSH terms:
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Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory