Condition category
Not Applicable
Date applied
10/06/2016
Date assigned
20/09/2016
Last edited
21/09/2016
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 Citrus sinensis (sweet orange) flower and Mentha spicata (spearmint) leaves 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 20 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 M. spicata oil mixed with 2ml of normal saline (salt water) which has been turned into a vapor. Those in the second group inhale C. sinensis flower 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 (devise used for measuring the about of air breathed in and out) to test their lung function. In addition, before and after inhalation, participants run 1500 metres in a stadium to find out if inhaling the oil has improved 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?
April 2016 to October 2016

Who is funding the study?
Investigator initiated and funded (Palestinian Territory)

Who is the main contact?
Dr Nidal Jaradat
nidaljaradat@najah.edu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nidal Jaradat

ORCID ID

http://orcid.org/0000-0003-2291-6821

Contact details

Faculty of Medicine and Health Sciences
An-Najah National University
Nablus
00970
Palestinian Territory
00970599739476
nidaljaradat@najah.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1/May/ 2016

Study information

Scientific title

The effect of Inhalation of Citrus sinensis flowers and Mentha spicata leave essential 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 compare the effects between the Citrus sinensis flower and Mentha spicata leaves essential oils inhalation among a group of athlete male students on their lung functions

Ethics approval

Institutional Review Board (IRB) at An Najah National University, 03/05/2016, ref: 1/May/2016

Study design

Single centre randomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

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

Exercise performance and lung function

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 participant level.

Group 1: Participants will nebulize with M. spicata oil (0.02ml/kg of body mass of oil) mixed with 2ml of normal saline.
Group 2: Participants will nebulize with C. sinensis flower oil (0.02ml/kg of body mass of oil) mixed with 2ml of normal saline.

Participants in both groups completed a 1500m run test in a stadium race before and after inhalation of the oils, they inhaled the oils 5 minutes before running. Lung function tests are undertaken using a spirometer before and after inhalation.

Intervention type

Phase

Drug names

Primary outcome measures

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

Secondary outcome measures

Athletic performance is measured using a 1500 meter run test before and after inhalation of volatile oil.

Overall trial start date

01/04/2016

Overall trial end date

01/10/2016

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 18-20 years

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

20

Participant exclusion criteria

Suffering any disease.

Recruitment start date

22/06/2016

Recruitment end date

22/07/2016

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

Department of Pharmacy
Palestine-West Bank
An-Najah National University
Nablus
00970
Palestinian Territory
+970 9 2345113
info@najah.edu

Sponsor type

University/education

Website

https://www.najah.edu/ar/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of study results in a peer reviewed journal.

Intention to publish date

01/10/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes