Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001224718
Ethics application status
Approved
Date submitted
11/08/2022
Date registered
12/09/2022
Date last updated
12/09/2022
Date data sharing statement initially provided
12/09/2022
Date results information initially provided
12/09/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of aromatherapy on metabolism
Scientific title
The effects of aromatherapy on metabolism in healthy male volunteers
Secondary ID [1] 307742 0
SCMH_IRB No:1091203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The effects of aromatherapy on metabolism in healthy volunteers 327318 0
Condition category
Condition code
Metabolic and Endocrine 324449 324449 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We study aromatheray by using rosewood essential oil. The essential oil was diluted to the concentration of 2.5 % by mixing 15 drops of the essential oil with six teaspoons of a carrier oil. One drop of the mixture was applied to and completed absorbed into a medical mask. The mask was worn by a participant for 30 minutes in a study clinic room under the supervision of the principal investigator. Each participant went through one such study session.
Intervention code [1] 324214 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332276 0
collecting blood samples for metabolomics analysis
This is an exploratory outcome. We will analyze the metabolomics data and investigate possible mechanisms caused by aromatherapy.
Timepoint [1] 332276 0
before aromatherapy and 30 minutes after aromatherapy
Secondary outcome [1] 412786 0
Meridian electrical conductance by meridian energy analysis device (MEAD). The average electrical conductance of 24 meridians in each subject will be calculated.
Timepoint [1] 412786 0
before aromatherapy and 30 minutes after aromatherapy
Secondary outcome [2] 412787 0
heart rate variability
Electrodes (small, plastic patches that stick to the skin) are placed at right arm on front of forearm and left arm on front of forearm. The electrodes are connected to an ECG machine by wires.
Timepoint [2] 412787 0
before aromatherapy and 30 minutes after aromatherapy

Eligibility
Key inclusion criteria
healthy volunteers
Minimum age
20 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects who are unable to read and sign the consent form
Subjects who had been diagnosed with a major illness, such as acute myocardial infarction, stroke, late-stage cancer, paralysis, and major organ transplantation

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/07/2021
Date of last participant enrolment
Anticipated
Actual
20/07/2021
Date of last data collection
Anticipated
Actual
20/07/2021
Sample size
Target
6
Accrual to date
Final
6
Recruitment outside Australia
Country [1] 24950 0
Taiwan, Province Of China
State/province [1] 24950 0
Changhua

Funding & Sponsors
Funding source category [1] 312012 0
Hospital
Name [1] 312012 0
Show Chwan Memorial Hospital
Country [1] 312012 0
Taiwan, Province Of China
Primary sponsor type
Hospital
Name
Show Chwan Memorial Hospital
Address
542,SEC 1 CHUNG-SHAN RD., CHANGHUA. TAIWAN 500,R.O.C.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 313534 0
None
Name [1] 313534 0
Address [1] 313534 0
Country [1] 313534 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311431 0
Institutional Review Board of Show Chwan Memorial Hospital
Ethics committee address [1] 311431 0
542,SEC 1 CHUNG-SHAN RD., CHANGHUA. TAIWAN 500,R.O.C.
Ethics committee country [1] 311431 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 311431 0
10/11/2020
Approval date [1] 311431 0
16/12/2020
Ethics approval number [1] 311431 0
1091203

Summary
Brief summary
Background: Aromatherapy and massage are applied in clinical settings for various human diseases. Aromatherapy is a form of alternative and complementary medicine. It is used for a variety of applications including mood enhancement, pain relief, improving cognitive function, and improving sleep disorder for diabetic patients with insomnia. However, limited studies investigated the effects of aromatherapy on metabolism, and most studies were mostly on animal models.
Purpose: The aims of this study are: (1) To evaluate the effects of aromatherapy on metabolism; and (2) to investigate the possible mechanism caused by aromatherapy intervention on metabolism.
Materials and methods: This is a prospective, pre-post comparison study. Six participants will be recruited in this study. The characteristics data will be collected in all participants. Rosewood will be chosen as the essential oils for aromatherapy in this study. Essential oils will be applied to all participants by inhalation for 30 minutes. Meridian electrical conductance, heart rate variability (HRV), and metabolomics analysis will be evaluated and compared before and after aromatherapy.
Expected outcomes: It is expected to understand more about the effect of aromatherapy on metabolism by undertaking 30 minute session aromatherapy intervention. The results will help elucidate the mechanism of metabolism caused by aromatherapy and may help in the development of novel formulations against human diseases and prevention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121074 0
Dr Chun-Yi Lin
Address 121074 0
Doctor of Medicine. Department of Nuclear Medicine, Show Chwan Memorial Hospital, Changhua, Taiwan. 542,SEC 1 CHUNG-SHAN RD., CHANGHUA. TAIWAN 500,R.O.C.
Country 121074 0
Taiwan, Province Of China
Phone 121074 0
+88697511183
Fax 121074 0
Email 121074 0
amy36372215@gmail.com
Contact person for public queries
Name 121075 0
Dr Hsing-Ju Wu
Address 121075 0
Research Fellow. Research Assistant Center, Show Chwan Memorial Hospital, 542,SEC 1 CHUNG-SHAN RD., CHANGHUA. TAIWAN 500,R.O.C.
Country 121075 0
Taiwan, Province Of China
Phone 121075 0
+886975611506
Fax 121075 0
Email 121075 0
hildawu09@gmail.com
Contact person for scientific queries
Name 121076 0
Mrs Chen-Chen Wang
Address 121076 0
Research Assistant. Research Assistant Center, Show Chwan Memorial Hospital, 542,SEC 1 CHUNG-SHAN RD., CHANGHUA. TAIWAN 500,R.O.C.
Country 121076 0
Taiwan, Province Of China
Phone 121076 0
+886975611854
Fax 121076 0
Email 121076 0
wchen502@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.