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Kinetics of Etheric Oils, Smart Textiles vs. Ointment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00299559
Recruitment Status : Completed
First Posted : March 7, 2006
Last Update Posted : February 13, 2009
Information provided by:
Technische Universität Dresden

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Common Cold Drug: smart textiles containing menthol, camphor, cineol Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Clinical Cross-Over Trial to Compare the Kinetics of Etheric Oils Applied Onto the Skin or Via Smart Textiles
Study Start Date : March 2006
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold

Arm Intervention/treatment
cross over application of both specimen
Drug: smart textiles containing menthol, camphor, cineol
application to skin

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Grade of convenience of each application form will obtained at the end of each study day [ Time Frame: 48 h ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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 identifier (NCT number): NCT00299559

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Department of clinical Pharmacology, Medical faculty Carl Gustav Carus, University of Technology Dresden
Dresden, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
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Principal Investigator: Joachim Siegert, MDDPharm,PhD Department of clinical Pharmacology, Medical Faculty Carl Gustav Carus, University of Technology

Layout table for additonal information Identifier: NCT00299559     History of Changes
Other Study ID Numbers: EK222122005
First Posted: March 7, 2006    Key Record Dates
Last Update Posted: February 13, 2009
Last Verified: November 2007

Keywords provided by Technische Universität Dresden:
common cold
organic chemicals
etheric oils
alternative medicine
smart textiles

Additional relevant MeSH terms:
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Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Dermatologic Agents
Anti-Infective Agents, Local
Anti-Infective Agents
Antitussive Agents
Respiratory System Agents
Insect Repellents
Protective Agents
Physiological Effects of Drugs