Common ColdPhase 1NCT00299559
Kinetics of Etheric Oils, Smart Textiles vs. Ointment
A Phase 1 study testing smart textiles containing menthol, camphor, cineol in people with Common Cold, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The purpose of the study is to determine whether the application form of etheric oils (camphor, cineol and menthol) causes changes in the concentration of this agents in the exhaled air. The second aim of the study is to determine differences in the subjective convenience of the application forms. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Cold
- What is being tested?
- smart textiles containing menthol, camphor, cineol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2006to Aug 2006
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- caucasian
- Broca-index: between -20 and +25%
- who are willing and capable to confirm written consent to enrolment after ample information has been provided
- who are in a stable condition that it can be expected that no changes in relevant medical conditions will occur during the study.
Who cannot join
- subjects with any major relevant clinical abnormality (as based on extensive medical history, physical examination, vital signs)
- subjects with any major clinically relevant laboratory abnormality.
- subjects who participated in another trial with any investigational substance within the last 4 weeks
- subjects who smoke more than 15 cigarettes per day
- subjects who are known or suspected to be (social) drug dependent, incl. those drinking more than moderately and who are not willing to abstain from alcohol during the active study phase
- subjects who adhere to a diet or lifestyle (incl. competitive sports and weight lifting) that might interfere with the investigation
- subjects who are known or suspected not to comply with the study directives and/or who are known or suspected not to be reliable or trustworthy
- subjects who are known or suspected not to be capable of understanding and evaluating the information that is given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of clinical Pharmacology, Medical faculty Carl Gustav Carus, University of Technology Dresden
Dresden, 01307
About this study
Official title: An Open Clinical Cross-Over Trial to Compare the Kinetics of Etheric Oils Applied Onto the Skin or Via Smart Textiles
The purpose of the study is to determine whether the application form of etheric oils (camphor, cineol and menthol) causes changes in the concentration of this agents in the exhaled air. The second aim of the study is to determine differences in the subjective convenience of the application forms. We will test an commercial ointment application vs. smart textiles. Smart textiles are new high-tech products with the unique possibility to combine the textiles with functional products e.g. pharmaceutical agents.
Read the detailed description
On the first appointment recruitment investigations will take place. After the person is enrolled to the study, the first determination of substances concentration in exhaled air and the convenience grade of the application form being exposed to will be achieved (study day 1). After a 7 days lasting washout phase on study day 2 newly determination of substances concentration and convenience grade of the other application will be assessed. Each study day will have an approximate duration of 11 h. During this time 9 samples of the persons exhaled air will be collected.
- Conditions
- Common Cold
- Being tested
- smart textiles containing menthol, camphor, cineol
- Keywords
- common cold, organic chemicals, menthol, cineole, camphor, etheric oils, alternative medicine, smart textiles
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smart textiles containing menthol, camphor, cineolDrug
application to skin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | cross over application of both specimen Receives: Drug: smart textiles containing menthol, camphor, cineol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of agents concentration in exhaled air on study day 1+2. On each day 9 samples of exhaled air will be obtained.
Measured: 24 h
Secondary outcomes (1)
Grade of convenience of each application form will obtained at the end of each study day
Measured: 48 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Joachim Siegert, MDDPharm,PhD, Principal investigator, Department of clinical Pharmacology, Medical Faculty Carl Gustav Carus, University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299559
- Sponsor's protocol ID
- EK222122005
- Status last verified
- Nov 2007
- First submitted
- 3 Mar 2006
- Last updated
- 13 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Clinical Cross-Over Trial to Compare the Kinetics of Etheric Oils Applied Onto the Skin or Via Smart Textiles
- ClinicalTrials.gov ID
- NCT00299559
- Acronym / sponsor ID
- EK222122005
- Conditions
- Common Cold
- Keywords
- common cold, organic chemicals, menthol, cineole, camphor, etheric oils, alternative medicine, smart textiles
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 7 Mar 2006 (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.
The purpose of the study is to determine whether the application form of etheric oils (camphor, cineol and menthol) causes changes in the concentration of this agents in the exhaled air. The second aim of the study is to determine differences in the subjective convenience of the application forms. We will test an commercial ointment application vs. smart textiles. Smart textiles are new high-tech products with the unique possibility to combine the textiles with functional products e.g. pharmaceutical agents.
Detailed description
On the first appointment recruitment investigations will take place. After the person is enrolled to the study, the first determination of substances concentration in exhaled air and the convenience grade of the application form being exposed to will be achieved (study day 1). After a 7 days lasting washout phase on study day 2 newly determination of substances concentration and convenience grade of the other application will be assessed. Each study day will have an approximate duration of 11 h. During this time 9 samples of the persons exhaled air will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: smart textiles containing menthol, camphor, cineolcross over application of both specimen |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- caucasian
- Broca-index: between -20 and +25%
- who are willing and capable to confirm written consent to enrolment after ample information has been provided
- who are in a stable condition that it can be expected that no changes in relevant medical conditions will occur during the study.
Key exclusion criteria (8 listed)
- subjects with any major relevant clinical abnormality (as based on extensive medical history, physical examination, vital signs)
- subjects with any major clinically relevant laboratory abnormality.
- subjects who participated in another trial with any investigational substance within the last 4 weeks
- subjects who smoke more than 15 cigarettes per day
- subjects who are known or suspected to be (social) drug dependent, incl. those drinking more than moderately and who are not willing to abstain from alcohol during the active study phase
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 |
|---|---|---|
| smart textiles containing menthol, camphor, cineolapplication to skin | Drug | 1 |
Primary outcome
Determination of agents concentration in exhaled air on study day 1+2. On each day 9 samples of exhaled air will be obtained.
Time frame: 24 h
1 secondary outcome
Grade of convenience of each application form will obtained at the end of each study day
Time frame: 48 h
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 13 Feb 2009.
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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.
Joachim Siegert, MDDPharm,PhD principal investigator
Department of clinical Pharmacology, Medical Faculty Carl Gustav Carus, University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing smart textiles containing menthol, camphor, cineol in people with Common Cold, run by Technische Universität Dresden at 1 site in Germany.
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 8 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 13 Feb 2009. 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 Germany. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Determination of agents concentration in exhaled air on study day 1+2. On each day 9 samples of exhaled air will be obtained. (time frame: 24 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2009.