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

This study has been completed.
Sponsor:
Information provided by:
Cardiff University
ClinicalTrials.gov Identifier:
NCT00495976
First received: July 2, 2007
Last updated: March 21, 2008
Last verified: November 2007
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Investigate the Effects of Hot Drinks on Nasal Airway Resistance and Symptoms of Common Cold

Resource links provided by NLM:

MedlinePlus related topics: Common Cold Flu
U.S. FDA Resources

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
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

Additional Information:
Common Cold Centre Cardiff University UK  This link exits the ClinicalTrials.gov site
Healthcare Clinical Trials  This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by Cardiff University:
common cold
flu
influenza

Additional relevant MeSH terms:
Common Cold
Respiratory Tract Infections
Picornaviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Diseases
Infection

ClinicalTrials.gov processed this record on May 16, 2013