NCT01575821

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 12, 2012

Completed
Last Updated

April 12, 2012

Status Verified

April 1, 2012

Enrollment Period

3.2 years

First QC Date

April 8, 2012

Last Update Submit

April 11, 2012

Conditions

CoughSleep

Keywords

children, cough, honey

Outcome Measures

Primary Outcomes (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).

    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)

Secondary Outcomes (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

    changes between two nights ( the night before treatment and the night with treatment)

Study Arms (4)

Eucalyptus honey ,

EXPERIMENTAL

75 children

Dietary Supplement: Eucalyptus honey

Labiatae honey

EXPERIMENTAL

75 children allocated

Dietary Supplement: Labiatae honey

Silan date extract (placebo)

EXPERIMENTAL

75 children allocated

Dietary Supplement: Silan date extract

Citrus honey

EXPERIMENTAL

75 children allocated

Dietary Supplement: Citrus honey

Interventions

Eucalyptus honeyDIETARY_SUPPLEMENT

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

Eucalyptus honey ,
Labiatae honeyDIETARY_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
Citrus honeyDIETARY_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
Silan date extractDIETARY_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)

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years of age complying of nocturnal cough that was attributed to a URI.

You may not qualify if:

  • asthma,
  • pneumonia,
  • laryngotracheobronchitis,
  • sinusitis,
  • allergic rhinitis,
  • use of cough or cold medication on the night before entering the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

6 General Pediatric Community Clinics

Petah Tikva, 56000, Israel

Location

Related Publications (2)

  • 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.

    PMID: 18056558BACKGROUND

  • 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.

    PMID: 22869830DERIVED

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cohen AV Herman

    Israel Clalit Health Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2012

First Posted

April 12, 2012

Study Start

January 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

April 12, 2012

Record last verified: 2012-04

Locations

IL(1)