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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01443871
Other study ID # WP-5102031
Secondary ID
Status Completed
Phase N/A
First received September 28, 2011
Last updated May 26, 2015
Start date September 2011
Est. completion date December 2014

Study information

Verified date May 2015
Source University of Phayao
Contact n/a
Is FDA regulated No
Health authority Thailand: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine and compare electroencephalography (EEG) changes in human subjects directly after inhalation of essential oils from five Thai aromatherapies. The investigators hypothesize that essential oils from Thai aromatherapies may influence the human EEG involving emotional relaxation particularly alpha wave EEG.


Description:

The subjects consisted of 22 male and 26 female subjects , ages between 20 to 30 years (mean age, 23.3 years). They were screened for excessive nasal congestion, drug and food taken, and neurological disorders prior to participation in the experiment. The experiments were approved by the Ethical Committee for Research Involving Human Research Subject, Naresuan University. All subjects read and signed an informed consent before participation.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date December 2014
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- > 18 years old

Exclusion Criteria:

- excessive nasal congestion

- neurological disorders prior to participation in the experiment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Other:
Aromatherapy
Subject will assigned inhale aromatherapy
Pure water
Subject will assigned inhale Pure water

Locations

Country Name City State
Thailand Surasak Saokaew Muang Phayao
Thailand University of Phayao Muang Phayao

Sponsors (1)

Lead Sponsor Collaborator
University of Phayao

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary electroencephalography (EEG) changes The EEG was assessed for 10 minutes in each period; baseline, during and after inhaled the essential oil baseline, 10 minutes No
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