Study on the Efficacy of Vetiver Essential Oil Aroma on Depression/Anxiety People
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2021
CompletedFirst Submitted
Initial submission to the registry
May 20, 2021
CompletedFirst Posted
Study publicly available on registry
August 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedJune 22, 2022
June 1, 2022
1.7 years
May 20, 2021
June 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The aromatherapy measure autonomic nerve parameter SDNN (standard deviation of all normal to normal intervals index)
one month
The measure blood pressure (SBP and DBP)
values change of systolic and diastolic BPs
one month
Study Arms (2)
Placebo
ACTIVE COMPARATORSubjects take 30 mins aromatherapy of Limon essential oil per time, a total of 3 times for the month.
Experimental
EXPERIMENTALSubjects take 30 mins aromatherapy of vetiver essential oil per time, a total of 3 times for the month.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chung Shan Medical University
Taichung, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
You-Cheng Mr Shen, Ph.D.
Chung Shan Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 20, 2021
First Posted
August 27, 2021
Study Start
January 20, 2021
Primary Completion
October 1, 2022
Study Completion
March 1, 2023
Last Updated
June 22, 2022
Record last verified: 2022-06