The roles of essential oils in the modulation of immune function: a pilot study
- Conditions
- Immunomodulation in smokers/non-smokersHaematological Disorders
- Registration Number
- ISRCTN10793328
- Lead Sponsor
- Fragrantia Investments (Australia)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 20
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Alterations in the immune system indicators being measured will be estimated via a series of blood tests; the measures include in vivo changes in:<br>1. Complete blood count including leucocyte count and differential<br>2. Lymphocyte subset phenotype<br>3. Natural killer cell activity<br>4. Erythrocyte sedimentation rate (ESR)<br>5. C-Reactive protein: high sensitivity assay (hsCRP)
- Secondary Outcome Measures
Name Time Method Secondary outcome measures include in vivo alterations in:<br>1. Lymphocyte cytokine production profile<br>2. Liver function tests<br>3. Urea, creatinine and electrolytes