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Tracking Information | |||||
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First Received Date † | July 2, 2007 | ||||
Last Updated Date | March 21, 2008 | ||||
Start Date † | September 2007 | ||||
Current Primary Outcome Measures † |
Change in nasal conductance of airflow from before the drink to immediately after the drink [ Time Frame: prospective ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00495976 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Exploratory analysis will also be made to investigate the relationship between objective measures of nasal airflow and the symptoms of common cold. [ Time Frame: prospective ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Study to Investigate the Effects of Hot Drinks on Nasal Airway Resistance and Symptoms of Common Cold | ||||
Official Title † | A Pilot Study to Investigate the Effects of Hot Drinks on Nasal Airway Resistance and Symptoms of Common Cold | ||||
Brief Summary | Common cold medicines are often formulated as a hot drink yet there is no evidence in the public domain that presenting the medicine as a hot drink has any impact on symptom severity. |
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Detailed Description | Common cold medicines are often formulated as a hot drink and usually contain paracetamol and a decongestant such as phenylephrine but it is the 'hot drink' formulation that is often an attraction to the patient in deciding on which formulation of a cold medicine to purchase and use. Hot drinks have been used to relieve the symptoms of acute respiratory infections such as colds and flu for hundreds of years and are found in the traditional medicines of countries throughout the world. The idea of using a hot drink to treat colds and flu appears to originate from a perceived link between exposure to cold and chilling and the onset of a respiratory infection. In order to combat the cold exposure many traditional remedies use a warming and soothing drink or application of a warming ointment . Despite the widespread folklore that hot drinks are an effective treatment for colds and flu, and the use of hot drink formulations for many current common cold medicines, there appears to be no evidence base in the medical literature supporting the efficacy of this common treatment for common cold. The aim of the present study is to obtain new knowledge about the effects of hot drinks on nasal airway resistance and other symptoms of common cold. |
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Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
Condition † | Common Cold/Flu | ||||
Intervention † | Other: A commercially produced cordial drink | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 60 | ||||
Completion Date | October 2007 | ||||
Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria: Subjects will not be enrolled in the study if any of the following criteria are met:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | United Kingdom | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00495976 | ||||
Responsible Party | Professor Ron Eccles, Cardiff University | ||||
Secondary IDs †† | |||||
Study Sponsor † | Cardiff University | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Cardiff University | ||||
Verification Date | November 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |