Condition category
Haematological Disorders
Date applied
20/06/2005
Date assigned
21/09/2005
Last edited
13/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Joan O'Connor

ORCID ID

Contact details

P.O. Box 157
Lismore
2480
Australia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ECN-04-52

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

A blend of essential oils

Primary outcome measures

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)

Secondary outcome measures

Secondary outcome measures include in vivo alterations in:
1. Lymphocyte cytokine production profile
2. Liver function tests
3. Urea, creatinine and electrolytes

Overall trial start date

01/06/2005

Overall trial end date

30/09/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

20

Participant 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

Recruitment start date

01/06/2005

Recruitment end date

30/09/2005

Locations

Countries of recruitment

Australia

Trial participating centre

P.O. Box 157
Lismore
2480
Australia

Sponsor information

Organisation

Fragrantia Investments (Australia)

Sponsor details

38 Dudley Road
Wonga Park Victoria
3155
Australia

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Sharon Kepper Aromatherapy - Fragrantia Investments (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes