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

Primary Purpose

Anxiety Depression Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Limon essential oil aromatherapy
Vetiver essential oil aromatherapy
Sponsored by
Chung Shan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anxiety Depression Disorder focused on measuring Vetiver oil, Aromatherapy, Anxiety, Depression

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chung Shan Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Placebo

Experimental

Arm Description

Subjects take 30 mins aromatherapy of Limon essential oil per time, a total of 3 times for the month.

Subjects take 30 mins aromatherapy of vetiver essential oil per time, a total of 3 times for the month.

Outcomes

Primary Outcome Measures

The aromatherapy measure autonomic nerve parameter SDNN (standard deviation of all normal to normal intervals index)
The measure blood pressure (SBP and DBP)
values change of systolic and diastolic BPs

Secondary Outcome Measures

Full Information

First Posted
May 20, 2021
Last Updated
June 20, 2022
Sponsor
Chung Shan Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05024136
Brief Title
Study on the Efficacy of Vetiver Essential Oil Aroma on Depression/Anxiety People
Official Title
Study on the Efficacy of Vetiver Essential Oil Aroma on Depression/Anxiety People
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Depression Disorder
Keywords
Vetiver oil, Aromatherapy, Anxiety, Depression

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Subjects take 30 mins aromatherapy of Limon essential oil per time, a total of 3 times for the month.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Subjects take 30 mins aromatherapy of vetiver essential oil per time, a total of 3 times for the month.
Intervention Type
Device
Intervention Name(s)
Limon essential oil aromatherapy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Vetiver essential oil aromatherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The aromatherapy measure autonomic nerve parameter SDNN (standard deviation of all normal to normal intervals index)
Time Frame
one month
Title
The measure blood pressure (SBP and DBP)
Description
values change of systolic and diastolic BPs
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Age 20-65 years old Exclusion Criteria: an alcoholic Uncontrolled diabetes Those who have had a stroke in the last year Pregnant and lactating women People with liver or heart disease Arrhythmia or those with a heart rhythm regulator Those whose heart has already been fitted with a cardiac catheter stent Those who have used central nervous system stimulants (regardless of the length of time) Those who are allergic to essential oils Those who have used aromatherapy within a month Subjects request to withdraw from the trial The host feels unsuitable to continue the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
You-Cheng Mr Shen, Ph.D.
Phone
886-4-24730022
Ext
12107
Email
youcheng@csmu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Chang-Yao Mr TSAO, MD/PhD.
Phone
886-4-24739595
Ext
21735
Email
irb@csh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
You-Cheng Mr Shen, Ph.D.
Organizational Affiliation
Chung Shan Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung Shan Medical University
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
You-Cheng Mr Shen, Ph.D.
Phone
886-4-24730022
Ext
12107
Email
youcheng@csmu.edu.tw

12. IPD Sharing Statement

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

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