Back to resultsStudy to Investigate the Effects of Hot Drinks on Nasal Airway Resistance and Symptoms of Common Cold
Primary Purpose
Common Cold/Flu
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
A commercially produced cordial drink
Sponsored by
About this trial
This is an interventional treatment trial for Common Cold/Flu focused on measuring common cold, flu, influenza
Eligibility 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
Sites / Locations
- Common Cold Centre and Healthcare Clinical Trials
Outcomes
Primary Outcome Measures
Change in nasal conductance of airflow from before the drink to immediately after the drink
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00495976
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cardiff University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold/Flu
Keywords
common cold, flu, influenza
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
A commercially produced cordial drink
Primary Outcome Measure Information:
Title
Change in nasal conductance of airflow from before the drink to immediately after the drink
Time Frame
prospective
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Eccles, D.Sc
Organizational Affiliation
Common Cold Centre and Healthcare Clinical Trials, Cardiff University, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Common Cold Centre and Healthcare Clinical Trials
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF10 3US
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19145994
Citation
Sanu A, Eccles R. The effects of a hot drink on nasal airflow and symptoms of common cold and flu. Rhinology. 2008 Dec;46(4):271-5.
Results Reference
result
Links:
URL
http://www.cf.ac.uk/biosi/subsites/cold/
Description
Common Cold Centre Cardiff University UK
URL
http://www.cf.ac.uk/biosi/subsites/cold/trial2.html
Description
Healthcare Clinical Trials
Learn more about this trial
Study to Investigate the Effects of Hot Drinks on Nasal Airway Resistance and Symptoms of Common Cold
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