Kinetics of Etheric Oils, Smart Textiles vs. Ointment

NCT00299559 | Completed Phase 1

• 1 other identifier: EK222122005
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Cold

Keywords

common cold; organic chemicals; menthol; cineole; camphor; etheric oils; alternative medicine; smart textiles

Outcome Measures

Primary Outcomes (1)

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

  24 h

Secondary Outcomes (1)

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

  48 h

Study Arms (1)

1

OTHER

cross over application of both specimen

Drug: smart textiles containing menthol, camphor, cineol

Interventions

smart textiles containing menthol, camphor, cineol DRUG

application to skin

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

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

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Common Cold

Interventions

Camphor

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camphanes; Bicyclic Monoterpenes; Bridged Bicyclo Compounds; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Norbornanes; Monoterpenes; Terpenes; Ketones; Polycyclic Compounds

Study Officials

• Joachim Siegert, MDDPharm,PhD

  Department of clinical Pharmacology, Medical Faculty Carl Gustav Carus, University of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 3, 2006
• First Posted: March 7, 2006
• Study Start: March 1, 2006
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: February 13, 2009

Record last verified: 2007-11

Locations

DE (1)