The Effect of Honey on Nocturnal Cough and Sleep Quality

NCT ID: NCT01575821

Last Updated: 2012-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-04-30

Brief Summary

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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

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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

Conditions

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Cough Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Eucalyptus honey ,

75 children

Group Type EXPERIMENTAL

Eucalyptus honey

Intervention Type DIETARY_SUPPLEMENT

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

75 children allocated

Group Type EXPERIMENTAL

Labiatae honey

Intervention Type DIETARY_SUPPLEMENT

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 (placebo)

75 children allocated

Group Type EXPERIMENTAL

Silan date extract

Intervention Type DIETARY_SUPPLEMENT

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

75 children allocated

Group Type EXPERIMENTAL

Citrus honey

Intervention Type DIETARY_SUPPLEMENT

Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ambulatory Pediatric Association

OTHER

Sponsor Role collaborator

Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cohen AV Herman

Role: PRINCIPAL_INVESTIGATOR

Israel Clalit Health Services

Locations

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6 General Pediatric Community Clinics

Petah Tikva, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
PMID: 18056558 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22869830 (View on PubMed)

Other Identifiers

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hermanhoney

Identifier Type: -

Identifier Source: org_study_id

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