Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep
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|ClinicalTrials.gov Identifier: NCT00127686|
Recruitment Status : Completed
First Posted : August 8, 2005
Last Update Posted : November 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cough Respiratory Tract Infections||Drug: Dextromethorphan Drug: Buckwheat Honey||Phase 1|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep Quality for Coughing Children and Their Parents|
|Study Start Date :||September 2005|
|Primary Completion Date :||December 2006|
|Study Completion Date :||December 2006|
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127686
|United States, Pennsylvania|
|Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17545|
|Principal Investigator:||Ian M Paul, MD, MSc||Penn State College of Medicine|