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

Phase 3

Completed

• Conditions: Immune function; Inflammatory and Immune System - Normal development and function of the immune system

• Registration Number: ACTRN12605000365662
• Lead Sponsor: Sharon Kepper Aromatherapy: Fragrantia Investments

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 20

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete blood count including leucocyte count and differential[Measured on days 0, 14, 28 and 42];Lymphocyte subset phenotype[Measured on days 0, 14, 28 and 42];Natural killer cell activity[Measured on days 0, 14, 28 and 42];Erythrocyte sedimentation rate (ESR)[Measured on days 0, 14, 28 and 42];C-Reactive protein[Measured on days 0, 14, 28 and 42];High sensitivity assay (hsCRP)[Measured on days 0, 14, 28 and 42];Ex-vivo changes in lymphocyte activation[Measured on days 0, 14, 28 and 42]

Secondary Outcome Measures

Name	Time	Method
In vivo alterations in lymphocyte cytokine production profile[Measured on Day 0, Day 14, Day 28 and Day 42.];In vivo alterations in liver function tests[Measured on Day 0, Day 14, Day 28 and Day 42.];In vivo alterations in urea, creatinine and electrolytes[Measured on Day 0, Day 14, Day 28 and Day 42.]