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

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ClinicalTrials.gov Identifier: NCT00495976
Recruitment Status : Completed
First Posted : July 3, 2007
Last Update Posted : June 19, 2018
Sponsor:
Information provided by:
Cardiff University

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.

Condition or disease Intervention/treatment Phase
Common Cold/Flu Other: A commercially produced cordial drink Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold




Primary Outcome Measures :
  1. Change in nasal conductance of airflow from before the drink to immediately after the drink [ Time Frame: prospective ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): 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

Additional Information:
Publications of Results:
Responsible Party: Professor Ron Eccles, Cardiff University
ClinicalTrials.gov Identifier: NCT00495976     History of Changes
Other Study ID Numbers: hot drink
First Posted: July 3, 2007    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018

Keywords provided by Cardiff University:
common cold
flu
influenza

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