- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00127686
Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep
Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep Quality for Coughing Children and Their Parents
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cough is one of the most common reasons for a doctor's visit in the United States and may be the most bothersome symptom for children with colds. It is particularly annoying at night because it can interrupt sleep for both coughing children and their parents. Dextromethorphan (DM), the most common over-the-counter (OTC) "cough medication," may not be as helpful for these symptoms as previously believed. Because of this, treatments are needed to better reduce the symptoms from a cold. Honey is a naturally occurring substance that may provide relief for cold symptoms. Children are being offered the opportunity to take part in this research because they have been diagnosed with a cold and have had difficulty sleeping due to their cough.
The purpose of this research is to use a survey to see if a single dose of honey or DM is better than no treatment at all for controlling nighttime cough in children, ages 2 to less than 18 years with a cold and if the medicine or honey helps the quality of sleep for the coughing children and their parents. DM has been approved by the Food and Drug Administration (FDA) and is available over the counter. The form of honey used in this study may also be purchased without a doctor's prescription.
About 125 male and female children from 2 to less than 18 years old will take part in this study at the Hershey Medical Center.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
Pennsylvania
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Hershey, Pennsylvania, United States, 17545
- Penn State Milton S. Hershey Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ages 2 to <18 years
- Cough due to upper respiratory tract infection (URI), as determined by physical examination
- Sleep difficulty on the preceding night attributed to frequent cough
- Ability to swallow liquids
- Willingness of the child's guardian to participate in a survey
Exclusion Criteria:
- Signs/symptoms of more serious/treatable disease
- Itchy, watery eyes
- Frequent sneezing, tachypnea (respiratory rate >95th percentile) or labored breathing; symptoms for 8 or more days.
- History of asthma in the past 2 years
- Chronic lung disease, or seizure disorder
- Allergic reaction to honey or DM
- Selective serotonin reuptake inhibitors (SSRIs) or anti-malarial drugs
- Diabetes mellitus or signs/symptoms of insulin resistance
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Compared with no treatment, honey and DM will: improve the sleep quality for children with cough due to URI and improve the sleep quality for the parents of children with cough due to URI
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ian M Paul, MD, MSc, Penn State College of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Signs and Symptoms, Respiratory
- Respiratory Tract Infections
- Cough
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Respiratory System Agents
- Antitussive Agents
- Dextromethorphan
Other Study ID Numbers
- 21163 (Other Identifier: City of Hope Medical Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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