UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052088 |
|---|---|
| Receipt number | R000059451 |
| Scientific Title | Effects for intake of blue rose water on Salivary Oxytocin and cortisol. |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2023/11/22 21:25:54 |
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Basic information
Public title
Effects for intake of blue rose water on Salivary Oxytocin and cortisol.
Acronym
Effects for intake of blue rose water on Salivary Oxytocin and cortisol.
Scientific Title
Effects for intake of blue rose water on Salivary Oxytocin and cortisol.
Scientific Title:Acronym
Effects for intake of blue rose water on Salivary Oxytocin and cortisol.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate of the effects of Blue Rose Water on oxytocin and cortisol.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary oxytocin 10 minutes before intervention and 10 minutes after intervention
Key secondary outcomes
Salivary cortisol 10 minutes before intervention and 1minutes after intervention
Questionnaire
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
100 mL of the test product is ingested at the time of testing.
Interventions/Control_2
Interventions/Control_3
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
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Japanese healthy female subjects, between 20 years and 49 years old (inclusive) at the time of consent.
Key exclusion criteria
1. Subjects who smoke tobacco.
2. Subjects who are alcoholic.
3. Subjects who have medical history that needs treatment or follow up.
4. Subjects who have some allergies of food or drug
5. Subjects who have plant allergy or allergic symptoms with aromatherapy.
6. Subjects who are taking medications that affect the autonomic nervous system.
7. Subjects who are olfactory disorder.
8. Subjects who participate in, at the time of initiation of this study, another test that interferes with this study or subjects who are scheduled to attend, during the tests, another test that interferes with this study.
9. Subjects who received chemical peel, laser treatment, light irradiation treatment, skin treatment such as injection, or surgery, or beauty therapy on the site of the skin test within 4 weeks by the start of the test.
10. Subjects who are judged as unsuitable by the investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Aoyagi |
Organization
KINJIRUSHI Co., Ltd
Division name
R&D Division
Zip code
454-8526
Address
2-6-1 Yahata-Hontori, Nakagawa-ku, Nagoya-shi, Aichi
TEL
052-361-3859
daisuke-aoyagi@kinjirushi.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Aoyagi |
Organization
KINJIRUSHI Co., Ltd
Division name
R&D Division
Zip code
454-8526
Address
2-6-1 Yahata-Hontori, Nakagawa-ku, Nagoya-shi, Aichi
TEL
052-361-3859
Homepage URL
daisuke-aoyagi@kinjirushi.co.jp
Sponsor or person
Institute
KINJIRUSHI Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
KINJIRUSHI Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical trial ethics committee
Address
3F Haseman Bldg., 2-11-6 Tomioka, Koto-ku, Tokyo , Japan
Tel
03-5646-2434
m-yabuki@saticine-md.co.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 | 09 | Month | 01 | 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
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
Terminated
Date of protocol fixation
| 2023 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | 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 | 09 | Month | 01 | Day |
Last modified on
| 2023 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059451
