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

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ClinicalTrials.gov Identifier: NCT05024136
Recruitment Status : Recruiting
First Posted : August 27, 2021
Last Update Posted : June 22, 2022
Sponsor:
Information provided by (Responsible Party):
You-Cheng Shen, Chung Shan Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anxiety Depression Disorder Device: Limon essential oil aromatherapy Device: Vetiver essential oil aromatherapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Study on the Efficacy of Vetiver Essential Oil Aroma on Depression/Anxiety People
Actual Study Start Date : January 20, 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. The aromatherapy measure autonomic nerve parameter SDNN (standard deviation of all normal to normal intervals index) [ Time Frame: one month ]
  2. The measure blood pressure (SBP and DBP) [ Time Frame: one month ]
    values change of systolic and diastolic BPs


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05024136


Contacts
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Contact: You-Cheng Mr Shen, Ph.D. 886-4-24730022 ext 12107 youcheng@csmu.edu.tw
Contact: Chang-Yao Mr TSAO, MD/PhD. 886-4-24739595 ext 21735 irb@csh.org.tw

Locations
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Taiwan
Chung Shan Medical University Recruiting
Taichung, Taiwan
Contact: You-Cheng Mr Shen, Ph.D.    886-4-24730022 ext 12107    youcheng@csmu.edu.tw   
Sponsors and Collaborators
Chung Shan Medical University
Investigators
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Principal Investigator: You-Cheng Mr Shen, Ph.D. Chung Shan Medical University
More Information
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Responsible Party: You-Cheng Shen, Associate Professor, Chung Shan Medical University
ClinicalTrials.gov Identifier: NCT05024136    
Other Study ID Numbers: CS1-20030
First Posted: August 27, 2021    Key Record Dates
Last Update Posted: June 22, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by You-Cheng Shen, Chung Shan Medical University:
Vetiver oil
Aromatherapy
Anxiety
Depression
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
 Behavioral Symptoms
Mood Disorders
Mental Disorders