Trial registered on ANZCTR


Trial ID
ACTRN12605000365662
Ethics application status
Approved
Date submitted
26/08/2005
Date registered
12/09/2005
Date last updated
21/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The roles of essential oils in the modulation of immune function: Pilot study
Scientific title
A pilot study to evaluate the potential roles for the topical application of aromatherapy essential oils in the modulation of immune function in healthy individuals
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immune function 460 0
Condition category
Condition code
Inflammatory and Immune System 537 537 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants undertook a 4-week period of topical use of an aromatherapy oil mix, followed by a 2 week post-treatment period.
Intervention code [1] 272 0
Treatment: Other
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 622 0
Complete blood count including leucocyte count and differential
Timepoint [1] 622 0
Measured on days 0, 14, 28 and 42
Primary outcome [2] 623 0
Lymphocyte subset phenotype
Timepoint [2] 623 0
Measured on days 0, 14, 28 and 42
Primary outcome [3] 624 0
Natural killer cell activity
Timepoint [3] 624 0
Measured on days 0, 14, 28 and 42
Primary outcome [4] 625 0
Erythrocyte sedimentation rate (ESR)
Timepoint [4] 625 0
Measured on days 0, 14, 28 and 42
Primary outcome [5] 626 0
C-Reactive protein
Timepoint [5] 626 0
Measured on days 0, 14, 28 and 42
Primary outcome [6] 627 0
High sensitivity assay (hsCRP)
Timepoint [6] 627 0
Measured on days 0, 14, 28 and 42
Primary outcome [7] 628 0
Ex-vivo changes in lymphocyte activation
Timepoint [7] 628 0
Measured on days 0, 14, 28 and 42
Secondary outcome [1] 1294 0
In vivo alterations in lymphocyte cytokine production profile
Timepoint [1] 1294 0
Measured on Day 0, Day 14, Day 28 and Day 42.
Secondary outcome [2] 1295 0
In vivo alterations in liver function tests
Timepoint [2] 1295 0
Measured on Day 0, Day 14, Day 28 and Day 42.
Secondary outcome [3] 1296 0
In vivo alterations in urea, creatinine and electrolytes
Timepoint [3] 1296 0
Measured on Day 0, Day 14, Day 28 and Day 42.

Eligibility
Key inclusion criteria
Willing to comply with study protocols. The smokers must consume 10 cigarettes per day, and have done so for at least a year. The non-smokers must have never smoked.
Minimum age
18 Years
Maximum age
60 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Factors resulting in exclusion include: any significant medical problem or chronic illness, including the findings on assessment of:o BMI >30 or <18, o undiagnosed hypertension oro pulse irregularities consistent with pathological cardiac dysrhythmia such as atrial fibrillationHistory of allergies to fragrances, current or recent dermatitis, regular use of medications, vitamin or supplement consumption, alcohol intake of more than 7 standard drinks per week or greater than 4 on heaviest day, high levels of exercise (extreme strenuous exercise for over 60 mins >twice per week) Recreational drug use, any acute illness or infection in the preceding 2 weeks.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 595 0
Commercial sector/Industry
Name [1] 595 0
Sharon Kepper Aromatherapy
Address [1] 595 0
Country [1] 595 0
Australia
Primary sponsor type
Individual
Name
Sharon Kepper Aromatherapy: Fragrantia Investments
Address
Country
Secondary sponsor category [1] 484 0
None
Name [1] 484 0
none
Address [1] 484 0
Country [1] 484 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1691 0
Southern Cross university Human Research Ethics Committee
Ethics committee address [1] 1691 0
Ethics committee country [1] 1691 0
Australia
Date submitted for ethics approval [1] 1691 0
Approval date [1] 1691 0
Ethics approval number [1] 1691 0
Ethics committee name [2] 1692 0
University of Queensland Human Research Ethics Committee
Ethics committee address [2] 1692 0
Ethics committee country [2] 1692 0
Australia
Date submitted for ethics approval [2] 1692 0
Approval date [2] 1692 0
Ethics approval number [2] 1692 0

Summary
Brief summary
Aromatherapy essential oils were applied topically over a 28 day period to determine their efficacy in modulating immune alterations, including those associated with smoking; and to determine if they form a safe and well-tolerated treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35756 0
Address 35756 0
Country 35756 0
Phone 35756 0
Fax 35756 0
Email 35756 0
Contact person for public queries
Name 9461 0
Professor Stephen Myers
Address 9461 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 9461 0
Australia
Phone 9461 0
+61 2 66203403
Fax 9461 0
+61 2 66203307
Email 9461 0
smyers@scu.edu.au
Contact person for scientific queries
Name 389 0
Joan O'Connor
Address 389 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 389 0
Australia
Phone 389 0
+61 2 66203649
Fax 389 0
+61 2 66203307
Email 389 0
joconnor@scu.edu.au