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The Effect of Honey on Nocturnal Cough and Sleep Quality

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01575821
Enrollment
300
Registered
2012-04-12
Start date
2009-01-31
Completion date
2012-04-30
Last updated
2012-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough, Sleep

Keywords

children, cough, honey

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

Interventions

DIETARY_SUPPLEMENTEucalyptus honey

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

DIETARY_SUPPLEMENTLabiatae honey

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

DIETARY_SUPPLEMENTCitrus honey

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

DIETARY_SUPPLEMENTSilan 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.

Sponsors

Ambulatory Pediatric Association
CollaboratorOTHER
Meir Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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).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

MeasureTime frameDescription
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 nightschanges 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.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026