Kinetics of Etheric Oils, Smart Textiles vs. Ointment

Technische Universität Dresden

Status and phase

Completed

Phase 1

Conditions

Common Cold

Treatments

Drug: smart textiles containing menthol, camphor, cineol

Study type

Interventional

Funder types

Other

Identifiers

NCT00299559

EK222122005

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts 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