Common Cold/FluNCT00495976
Study to Investigate the Effects of Hot Drinks on Nasal Airway Resistance and Symptoms of Common Cold
A study testing A commercially produced cordial drink in people with Common Cold/Flu, run by Cardiff University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Common Cold/Flu
- What is being tested?
- A commercially produced cordial drink
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2007to Oct 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Common Cold Centre and Healthcare Clinical Trials
Cardiff, Wales, CF10 3US
About this study
Official title: 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.
Read the 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.
- Conditions
- Common Cold/Flu
- Being tested
- A commercially produced cordial drink
- Keywords
- common cold, flu, influenza
- Medical subject headings
- Common Cold, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A commercially produced cordial drinkOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nasal conductance of airflow from before the drink to immediately after the drink
Measured: prospective
Secondary outcomes (1)
Exploratory analysis will also be made to investigate the relationship between objective measures of nasal airflow and the symptoms of common cold.
Measured: prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study startSep 2007
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Common Cold/FluStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff University
- Sponsor type
- University, hospital or other
- Investigators
- Ron Eccles, D.Sc, Principal investigator, Common Cold Centre and Healthcare Clinical Trials, Cardiff University, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495976
- Sponsor's protocol ID
- hot drink
- Status last verified
- Jun 2018
- First submitted
- 2 Jul 2007
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19145994
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate the Effects of Hot Drinks on Nasal Airway Resistance and Symptoms of Common Cold
- ClinicalTrials.gov ID
- NCT00495976
- Acronym / sponsor ID
- hot drink
- Conditions
- Common Cold/Flu
- Keywords
- common cold, flu, influenza
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cardiff UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 3 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A commercially produced cordial drink | Other | – |
Primary outcome
Change in nasal conductance of airflow from before the drink to immediately after the drink
Time frame: prospective
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Results publication: PubMed 19145994Sanu 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.
- Common Cold Centre Cardiff University UKLink provided by the sponsor.
- Healthcare Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Eccles, D.Sc principal investigator
Common Cold Centre and Healthcare Clinical Trials, Cardiff University, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A commercially produced cordial drink in people with Common Cold/Flu, run by Cardiff University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nasal conductance of airflow from before the drink to immediately after the drink (time frame: prospective). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00495976, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.