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ISRCTN
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ISRCTN10793328
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ClinicalTrials.gov identifier
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Public title
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The roles of essential oils in the modulation of immune function: a pilot study
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Scientific title
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Acronym
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N/A
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Serial number at source
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ECN-04-52
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Study hypothesis
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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.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Australia
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Disease/condition/study domain
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Immunomodulation in smokers/non-smokers
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/06/2005
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Anticipated end date
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30/09/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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20
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Interventions
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A blend of essential oils, at a total of 10%, in a carrier of unfragranced white lotion base.
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Primary outcome measure(s)
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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)
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Secondary outcome measure(s)
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Secondary outcome measures include in vivo alterations in:
1. Lymphocyte cytokine production profile
2. Liver function tests
3. Urea, creatinine and electrolytes
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Sources of funding
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Sharon Kepper Aromatherapy - Fragrantia Investments (Australia)
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Trial website
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Publications
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Contact name
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Dr
Joan
O'Connor
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Address
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P.O. Box 157
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City/town
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Lismore
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Zip/Postcode
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2480
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Country
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Australia
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Sponsor
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Fragrantia Investments (Australia)
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Address
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38 Dudley Road
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City/town
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Wonga Park Victoria
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Zip/Postcode
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3155
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Country
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Australia
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Date applied
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20/06/2005
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Last edited
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13/09/2011
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Date ISRCTN assigned
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21/09/2005
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