Study on the Efficacy of Vetiver Essential Oil Aroma on Depression/Anxiety People

June 20, 2022 updated by: You-Cheng Shen, Chung Shan Medical University
In this study, subjects with depression/anxiety inhaled the essential oil, which contained sedative, soothing, and relaxing active ingredients to stimulate the olfactory nerve. The essential oil further transmitted to the limbic system that controls emotions in the brain, and then affected the human's mood. The natural aroma can not only awaken the limbic system's memory of aroma but also reflect the subconscious area of the brain, with physiological changes (such as controlling blood pressure, breathing, heartbeat, stress changes, memory, and hormonal coordination.) This study monitors the subject's autonomic nerve parameters before and after aromatherapy to obtain the olfactory cerebral nervous system to convey the message. When the study finishes, we expected to help the subject to relax and soothe the mind.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Subjects receive three times 30 mins aromatherapy of Limon or Vetiver essential oil per time for the month. Anthropometric measurements such as blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), autonomic nerve parameters including a. SDNN (standard deviation of all normal to normal intervals index); b. HRV（heart rate variability）; c. LF（0.04-0.15 Hz）and HF（0.15-0.4 Hz）were measured every week. PSQI（Pittsburgh sleep quality index）and HADS (Hospital Anxiety and Depression Scale) were measured initial and ten ends.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Chang-Yao Mr TSAO, MD/PhD.
  • Phone Number: 21735 886-4-24739595
  • Email: irb@csh.org.tw

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • Recruiting
        • Chung Shan Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Depressed/anxious people (diagnosed as a single episode of major depression, recurrence of major depression, mild depression, panic disorder, and anxiety.) Those diagnosed with symptoms of depression, and anxiety related to stress adjustment disorder, and willing to cooperate with the study.
  2. Age 20-65 years old

Exclusion Criteria:

  1. an alcoholic
  2. Uncontrolled diabetes
  3. Those who have had a stroke in the last year
  4. Pregnant and lactating women
  5. People with liver or heart disease
  6. Arrhythmia or those with a heart rhythm regulator
  7. Those whose heart has already been fitted with a cardiac catheter stent
  8. Those who have used central nervous system stimulants (regardless of the length of time)
  9. Those who are allergic to essential oils
  10. Those who have used aromatherapy within a month
  11. Subjects request to withdraw from the trial
  12. The host feels unsuitable to continue the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Placebo
Subjects take 30 mins aromatherapy of Limon essential oil per time, a total of 3 times for the month.
Device: Limon essential oil aromatherapy
Subjects receive three times 30 mins aromatherapy of Limon essential oil per time for the month. Anthropometric measurements such as blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), autonomic nerve parameters including a. SDNN (standard deviation of all normal to normal intervals index); b. HRV（heart rate variability）; c. LF（0.04-0.15 Hz）and HF（0.15-0.4 Hz）were measured every week. PSQI（Pittsburgh sleep quality index）and HADS (Hospital Anxiety and Depression Scale) were measured initial and ten ends.
Experimental: Experimental
Subjects take 30 mins aromatherapy of vetiver essential oil per time, a total of 3 times for the month.
Device: Vetiver essential oil aromatherapy
Subjects receive three times 30 mins aromatherapy of vetiver essential oil per time for the month. Anthropometric measurements such as blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), autonomic nerve parameters including a. SDNN (standard deviation of all normal to normal intervals index); b. HRV（heart rate variability）; c. LF（0.04-0.15 Hz）and HF（0.15-0.4 Hz）were measured every week. PSQI（Pittsburgh sleep quality index）and HADS (Hospital Anxiety and Depression Scale) were measured initial and ten ends.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The aromatherapy measure autonomic nerve parameter SDNN (standard deviation of all normal to normal intervals index)
Time Frame: one month
one month
The measure blood pressure (SBP and DBP)
Time Frame: one month
values change of systolic and diastolic BPs
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2021

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

August 26, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 20, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS1-20030

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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