- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00495976
Study to Investigate the Effects of Hot Drinks on Nasal Airway Resistance and Symptoms of Common Cold
June 15, 2018 updated by: Cardiff University
A Pilot Study to Investigate the Effects of Hot Drinks on Nasal Airway Resistance and Symptoms of Common Cold
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wales
-
Cardiff, Wales, United Kingdom, CF10 3US
- Common Cold Centre and Healthcare Clinical Trials
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in nasal conductance of airflow from before the drink to immediately after the drink
Time Frame: prospective
|
prospective
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
prospective
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ron Eccles, D.Sc, Common Cold Centre and Healthcare Clinical Trials, Cardiff University, UK
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
July 2, 2007
First Submitted That Met QC Criteria
July 2, 2007
First Posted (Estimate)
July 3, 2007
Study Record Updates
Last Update Posted (Actual)
June 19, 2018
Last Update Submitted That Met QC Criteria
June 15, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- hot drink
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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