The roles of essential oils in the modulation of immune function: a pilot study

ISRCTN	ISRCTN10793328
DOI	https://doi.org/10.1186/ISRCTN10793328
Protocol serial number	ECN-04-52
Sponsor	Fragrantia Investments (Australia)
Funder	Sharon Kepper Aromatherapy - Fragrantia Investments (Australia)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Joan O'Connor
Scientific

P.O. Box 157
Lismore
2480
Australia

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	That aromatherapy essential oils applied topically over a 28 day period are potentially effective in modulating immune alterations, including those associated with smoking; and that they can form a safe and well-tolerated treatment.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Immunomodulation in smokers/non-smokers
Intervention	A blend of essential oils, at a total of 10%, in a carrier of unfragranced white lotion base.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	A blend of essential oils
Primary outcome measure(s)	Alterations in the immune system indicators being measured will be estimated via a series of blood tests; the measures include in vivo changes in: 1. Complete blood count including leucocyte count and differential 2. Lymphocyte subset phenotype 3. Natural killer cell activity 4. Erythrocyte sedimentation rate (ESR) 5. C-Reactive protein: high sensitivity assay (hsCRP)
Key secondary outcome measure(s)	Secondary outcome measures include in vivo alterations in: 1. Lymphocyte cytokine production profile 2. Liver function tests 3. Urea, creatinine and electrolytes
Completion date	30/09/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	Male
Target sample size at registration	20
Key inclusion criteria	Participants are to be: 1. Aged 18-60 years 2. Male 3. Willing to comply with study protocols 4. The smokers must consume 10 cigarettes per day, and have done so for at least a year 5. The non-smokers must have never smoked
Key exclusion criteria	Factors resulting in exclusion include: 1. any significant medical problem or chronic illness including the findings on assessment of: a. Body mass index (BMI) >30 or <18 b. Undiagnosed hypertension c. Pulse irregularities consistent with pathological cardiac dysrhythmia such as atrial fibrillation 2. History of allergies to fragrances 3. Current or recent dermatitis 4. Regular use of medications 5. Vitamin or supplement consumption 6. Alcohol intake of more than 7 standard drinks per week or greater than 4 on heaviest day 7. High levels of exercise (extreme strenuous exercise for over 60 min >twice per week) 8. Recreational drug use 9. Any acute illness or infection in the preceding 2 weeks
Date of first enrolment	01/06/2005
Date of final enrolment	30/09/2005

P.O. Box 157

Lismore
2480
Australia

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan