CoughNCT01575821
The Effect of Honey on Nocturnal Cough and Sleep Quality
A study testing Eucalyptus honey, Labiatae honey and Citrus honey in people with Cough and Sleep, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- What is being tested?
- Eucalyptus honey, Labiatae honey and Citrus honey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1-5 years of age complying of nocturnal cough that was attributed to a URI.
Who cannot join
- asthma,
- pneumonia,
- laryngotracheobronchitis,
- sinusitis,
- allergic rhinitis,
- use of cough or cold medication on the night before entering the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Honey on Nocturnal Cough and Sleep Quality: a Double-blind, Randomized,Placebo-controlled Study
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
Read the 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
- Being tested
- Eucalyptus honey, Labiatae honey, Citrus honey, Silan date extract
- Keywords
- children, cough, honey
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Eucalyptus honey , | Experimental | 75 children Receives: Dietary Supplement: Eucalyptus honey |
| Labiatae honey | Experimental | 75 children allocated Receives: Dietary Supplement: Labiatae honey |
| Silan date extract (placebo) | Experimental | 75 children allocated Receives: Dietary Supplement: Silan date extract |
| Citrus honey | Experimental | 75 children allocated Receives: Dietary Supplement: Citrus honey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Assessment was been done by completing the pre and post intervention questionnaire as was described in the " primary outcome measurment".
Measured: changes between two nights ( the night before treatment and the night with treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startJan 2009
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ambulatory Pediatric Association
- Responsible party
- Sponsor
- Investigators
- Cohen AV Herman, Principal investigator, Israel Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575821
- Sponsor's protocol ID
- hermanhoney
- Status last verified
- Apr 2012
- First submitted
- 8 Apr 2012
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18056558Cohen 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.
PubMed 22869830
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Honey on Nocturnal Cough and Sleep Quality: a Double-blind, Randomized,Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01575821
- Acronym / sponsor ID
- hermanhoney
- Keywords
- children, cough, honey
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- Ambulatory Pediatric Association
- Study start
- Jan 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 12 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Eucalyptus honey , | Experimental | Dietary Supplement: Eucalyptus honey75 children |
| Labiatae honey | Experimental | Dietary Supplement: Labiatae honey75 children allocated |
| Silan date extract (placebo) | Experimental | Dietary Supplement: Silan date extract75 children allocated |
| Citrus honey | Experimental | Dietary Supplement: Citrus honey75 children allocated |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1-5 years of age complying of nocturnal cough that was attributed to a URI.
Key exclusion criteria (6 listed)
- asthma,
- pneumonia,
- laryngotracheobronchitis,
- sinusitis,
- allergic rhinitis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eucalyptus honeyParents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep. | Dietary supplement | Eucalyptus honey , |
| Labiatae honeyParents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep. | Dietary supplement | Labiatae honey |
| Citrus honeyParents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep. | Dietary supplement | Citrus honey |
| Silan date extractParents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep. | Dietary supplement | Silan date extract (placebo) |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2012.
- Background: PubMed 18056558Paul 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.
- Derived from this study: PubMed 22869830Cohen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cohen AV Herman principal investigator
Israel Clalit Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eucalyptus honey, Labiatae honey and Citrus honey in people with Cough and Sleep, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01575821, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2012.