Condition category
Respiratory
Date applied
27/09/2016
Date assigned
20/11/2016
Last edited
18/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Recently, there has been a lot of interest in the effects of essential oils on athletic performance and health. Essential oils are natural oils which are taken from plants and other natural sources. They have been used for many years in alternative medicine, as they are thought to help improve the function of the mind and body. This study will look at oils from the Clinopodium serpyllifolium (white micromeria - a type of evergreen shrub) and Cymbopogon citratus (lemon grass) plants to find out if they are able to improve lung function and athletic performance in healthy male athletes.

Who can participate?
Healthy male university students aged between 18 and 22 from the faculty of physical education at An-Najah National University in Nablus-Palestine.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group inhale Clinopodium serpyllifolium volatile oil mixed with 2ml of normal saline (salt water) which has been turned into a vapor. Those in the second group inhale Cymbopogon citratus volatile oil mixed with 2ml of normal saline (salt water) which has been turned into a vapor. Before and five minutes after inhalation, participants complete a breathing test using a spirometer (device used for measuring the about of air breathed in and out) to test their lung function. In addition, before and after inhalation, participants run 800 metres in a stadium to find out if inhaling the oil will improve their athletic performance.

What are the possible benefits and risks of participating?
Participants may benefit from improved lung function and athletic performance as a result of taking part in the study. There are no notable risks involved with taking part in this study.

Where is the study run from?
An-Najah National University (Palestinian Territory)

When is the study starting and how long is it expected to run for?
May 2016 to November 2016

Who is funding the study?
An-Najah National University (Palestinian Territory)

Who is the main contact?
Dr Hamzeh Al Zabadi
halzabadi@najah.edu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hamzeh Al Zabadi

ORCID ID

http://orcid.org/0000-0002-0721-9561

Contact details

Faculty of Medicine and Health Sciences
An-Najah National University
Nablus
00970
Palestinian Territory
+970 59 8046276
halzabadi@najah.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effects of inhalation of Clinopodium serpyllifolium and Cymbopogon citratus volatile oils on lung function and exercise performance: A quasi-experimental uncontrolled before-and-after study

Acronym

Study hypothesis

The aim of this study is to examine the effects of inhalation of Clinopodium serpyllifolium and Cymbopogon citratus volatile oils on a group of athlete male students on their lung functions and exercise performance.

Ethics approval

Institutional Review Board (IRB) at An Najah National University, 30/08/2016, ref: 11/08/2016

Study design

Single-centre non randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Lung function and exercise performance

Intervention

Twenty male university students from the faculty of physical education at An-Najah National University in Nablus-Palestine will be randomly assigned into two different groups. The study is single blind at participant level.

Group 1: Participants will nebulize with Clinopodium serpyllifolium oil (0.02ml/kg of body mass of oil) mixed with 2ml of normal saline.
Group 2: Participants will nebulize with Cymbopogon citratus oil (0.02ml/kg of body mass of oil) mixed with 2ml of normal saline.

Participants in both groups will complete a 800 m run test in a stadium race before and after inhalation of the oils, they will inhale the oils five minutes before running. Lung function tests will be undertaken using a spirometer before and 5 minutes after inhalation.

Intervention type

Phase

Drug names

Primary outcome measures

Lung function is measured using spirometry before and 5 minutes after inhalation of the volatile oils.

Secondary outcome measures

Athletic performance is measured using a 800 meter run test before and after inhalation of the volatile oils.

Overall trial start date

01/05/2016

Overall trial end date

10/11/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy
2. Male university students from the faculty of physical education at An-Najah National University in Nablus, Palestine
3. Aged between 18-22 years

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

20

Participant exclusion criteria

Suffering any disease.

Recruitment start date

15/10/2016

Recruitment end date

25/10/2016

Locations

Countries of recruitment

Palestinian Territory

Trial participating centre

An-Najah National University
West Bank
Nablus
00970
Palestinian Territory

Sponsor information

Organisation

An-Najah National University

Sponsor details

Public Health Division
Nablus
00970
Palestinian Territory
+970 59 8046276
halzabadi@najah.edu

Sponsor type

University/education

Website

https://www.najah.edu/en/

Funders

Funder type

University/education

Funder name

An-Najah National University

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned for publication of study results in a peer reviewed journal.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Hamzeh Al Zabadi (halzabadi@gmail.com)

Intention to publish date

01/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes