UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054112 |
|---|---|
| Receipt number | R000058840 |
| Scientific Title | Validation of the effect of shell ginger essential oil on menopausal depressive symptoms |
| Date of disclosure of the study information | 2024/04/11 |
| Last modified on | 2024/04/11 08:10:09 |
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Basic information
Public title
Validation of the effect of shell ginger essential oil on menopausal depressive symptoms
Acronym
Validation of the effect of essential oil on menopausal depressive symptoms
Scientific Title
Validation of the effect of shell ginger essential oil on menopausal depressive symptoms
Scientific Title:Acronym
Validation of the effect of essential oil on menopausal depressive symptoms
Region
| Japan |
Condition
Condition
Menopausal or post-menopausal depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of aromatherapy using Shell ginger, Tyrin shell ginger and Shikuwasa aroma for depressive state in menopausal or postmenopausal women.
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
Parallel
Randomization
Non-randomized
Randomization unit
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
Shima shell ginger essential oil
Interventions/Control_2
Tyrin shell ginger essential oil
Interventions/Control_3
Shikwasa essential oil
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
| 35 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
Menopausal or post-menopausal women who are basically in good health but have recently suffered from depression, and who prefer at least one of the scents of Shima shell ginger, Tyrin shell ginger and Shikuwasa essential oil.
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) Those who are carrying out aromatherapy
(4) Those who have difficulty communicating
(5) Those who don't like the scent of Shima shell ginger, Tyrin Shima shell ginger, and shikuwasa essential oil
(6) Others that the attending physician deems inappropriate for registration in this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kimio |
| Middle name | |
| Last name | Sugaya |
Organization
Southern Knights' Laboratory, Co., Ltd.
Division name
CEO
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
Southern Knights' Laboratory, Co., Ltd.
Division name
CEO
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
Kitakami Central Hospital Ethics Committee
Address
631-9 Kamisedo, Chatan, Okinawa, Japan
Tel
0989365111
kitakami@ryucom.ne.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
| 2024 | Year | 04 | Month | 11 | 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
60
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
| 2023 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 11 | Day |
Last modified on
| 2024 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058840
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
