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Completed

NCT Number: NCT01575821

The Effect of Honey on Nocturnal Cough and Sleep Quality

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

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Key information

Conditions

Cough Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

6 General Pediatric Community Clinics

Petah Tikva, 56000, Israel

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eucalyptus honey

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

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

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

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.

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).

    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 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

    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".

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Collaborators

  • Ambulatory Pediatric Association

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 12, 2012
Registry last updated
Apr 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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