UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051570 |
|---|---|
| Receipt number | R000056610 |
| Scientific Title | A clinical study on the efficacy and safety of the scent of essential oils for depression |
| Date of disclosure of the study information | 2023/07/10 |
| Last modified on | 2023/07/10 15:23:41 |
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Basic information
Public title
A clinical study on the efficacy and safety of the scent of essential oils for depression
Acronym
A clinical study of essential oils for depression
Scientific Title
A clinical study on the efficacy and safety of the scent of essential oils for depression
Scientific Title:Acronym
A clinical study of essential oils for depression
Region
| Japan |
Condition
Condition
depressive state
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate whether the aromas of shell ginger and tyrin shell ginger, which are said to have a relaxing effect, and the citrus shikuwasa aroma, which is said to have a refreshing effect, are effective for depressive state in adult women with depression.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quick Inventory of Depressive Symptomatology (QIDS) and Plasma Serotonin Levels
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
shell ginger aroma
Interventions/Control_2
tyrin shell ginger aroma
Interventions/Control_3
citrus shikuwasa aroma
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
Women aged 20 years or older who are basically healthy but have recently suffered from depression
Key exclusion criteria
(1) Subjects who are undergoing treatment for depression or who are taking its supplements
(2) Within 6 months after completion of treatment for depression
(3) Things that are carrying out aromatherapy
(4) Those who have difficulty communicating
(5) Others that the attending physician judges to be inappropriate for registration in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kimio |
| Middle name | |
| Last name | Sugaya |
Organization
Kitakami Central Hospital/Southern Knights' Laboratory
Division name
Urology
Zip code
904-0113
Address
1-1-823 Miyagi, Chatan, Okinawa, Japan
TEL
09049987459
sugaya@sklabo.co.jp
Public contact
Name of contact person
| 1st name | Kimio |
| Middle name | |
| Last name | Sugaya |
Organization
Kitakami Central Hospital/Southern Knights' Laboratory
Division name
Urology
Zip code
904-0113
Address
1-1-823 Miyagi, Chatan, Okinawa, Japan
TEL
09049987459
Homepage URL
https://sklabo.co.jp/
sugaya@sklabo.co.jp
Sponsor or person
Institute
Okinawa Prefecture
Institute
Department
Personal name
Funding Source
Organization
Okinawa Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawahara Department of Urology Ethics Committee
Address
73-3 Nishimochida, Aira City, Kagoshima, Japan
Tel
0995-64-5181
yamashita.hami@kawahara.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 10 | Day |
Last modified on
| 2023 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056610
