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Kinetics of Etheric Oils, Smart Textiles vs. Ointment

Primary Purpose

Common Cold

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
smart textiles containing menthol, camphor, cineol
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Cold focused on measuring common cold, organic chemicals, menthol, cineole, camphor, etheric oils, alternative medicine, smart textiles

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of clinical Pharmacology, Medical faculty Carl Gustav Carus, University of Technology Dresden

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

cross over application of both specimen

Outcomes

Primary Outcome Measures

Determination of agents concentration in exhaled air on study day 1+2. On each day 9 samples of exhaled air will be obtained.

Secondary Outcome Measures

Grade of convenience of each application form will obtained at the end of each study day

Full Information

First Posted
March 3, 2006
Last Updated
February 12, 2009
Sponsor
Technische Universität Dresden
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1. Study Identification

Unique Protocol Identification Number
NCT00299559
Brief Title
Kinetics of Etheric Oils, Smart Textiles vs. Ointment
Official Title
An Open Clinical Cross-Over Trial to Compare the Kinetics of Etheric Oils Applied Onto the Skin or Via Smart Textiles
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Technische Universität Dresden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold
Keywords
common cold, organic chemicals, menthol, cineole, camphor, etheric oils, alternative medicine, smart textiles

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
cross over application of both specimen
Intervention Type
Drug
Intervention Name(s)
smart textiles containing menthol, camphor, cineol
Intervention Description
application to skin
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Grade of convenience of each application form will obtained at the end of each study day
Time Frame
48 h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joachim Siegert, MDDPharm,PhD
Organizational Affiliation
Department of clinical Pharmacology, Medical Faculty Carl Gustav Carus, University of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of clinical Pharmacology, Medical faculty Carl Gustav Carus, University of Technology Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

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Kinetics of Etheric Oils, Smart Textiles vs. Ointment

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