Study to Investigate the Effects of Hot Drinks on Nasal Airway Resistance and Symptoms of Common Cold - Full Text View

Sponsored by:	Cardiff University
Information provided by:	Cardiff University
ClinicalTrials.gov Identifier:	NCT00495976

Purpose

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.

Condition	Intervention
Common Cold/Flu	Other: A commercially produced cordial drink

MedlinePlus related topics: Common Cold Flu

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Pilot Study to Investigate the Effects of Hot Drinks on Nasal Airway Resistance and Symptoms of Common Cold

Further study details as provided by Cardiff University:

Primary Outcome Measures:

Change in nasal conductance of airflow from before the drink to immediately after the drink [ Time Frame: prospective ]

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 ]

Enrollment:	60
Study Start Date:	September 2007
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Aged over 18 years.
Has given informed consent.
Is suffering from common cold/flu like illness
Indicates they are suffering from at least three common cold symptoms (runny nose, sneezing, blocked nose, sore throat, cough) and scores at least 2 symptoms as moderate on four point ordinal scale of (0=not present, 1=mild, 2=moderate, 3=severe)

Exclusion Criteria:

Subjects will not be enrolled in the study if any of the following criteria are met:

The subject is unwilling to sign the consent form.
The subject has a clinically significant cardiovascular, endocrinological, neurological, respiratory, gastrointestinal disease or any other disease that is considered by the investigator as a reason for exclusion.
The subject has a severe nasal septal deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps.
The subject has had nasal surgery in the past that in the opinion of the investigator may influence symptom scores or nasal airway resistance
The subject has ingested any alcohol within the previous 12 hours or more than 4 units of alcohol in the previous 24 hours
The subject is a drug or alcohol abuser
The subject is taking any prescribed medication other than for contraception
The subject has had common cold for more than 7 days
The subject has recently taken a common cold medicine that in the opinion of the investigator may influence symptom scores or nasal airway resistance (analgesics, nasal decongestants, cough medicines)
The subject has ingested any hot food or drink within the previous hour

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495976

Locations

United Kingdom, Wales
Common Cold Centre and Healthcare Clinical Trials
Cardiff, Wales, United Kingdom, CF10 3US

Sponsors and Collaborators

Cardiff University

Investigators

Principal Investigator:

Ron Eccles, D.Sc

Common Cold Centre and Healthcare Clinical Trials, Cardiff University, UK

More Information

Common Cold Centre Cardiff University UK This link exits the ClinicalTrials.gov site

Healthcare Clinical Trials This link exits the ClinicalTrials.gov site

Responsible Party:	Cardiff University ( Professor Ron Eccles )
Study ID Numbers:	hot drink
Study First Received:	July 2, 2007
Last Updated:	March 21, 2008
ClinicalTrials.gov Identifier:	NCT00495976
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Cardiff University:

common cold
flu
influenza

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Common Cold
Influenza, Human
Picornaviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009