UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042194 |
|---|---|
| Receipt number | R000048028 |
| Scientific Title | The effect of the test substance on oral function, stress and immunity. |
| Date of disclosure of the study information | 2020/10/22 |
| Last modified on | 2021/04/21 12:59:35 |
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Basic information
Public title
The effect of the test substance on oral function, stress and immunity.
Acronym
The effect of the test substance on oral function, stress and immunity.
Scientific Title
The effect of the test substance on oral function, stress and immunity.
Scientific Title:Acronym
The effect of the test substance on oral function, stress and immunity.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effects of using the test substance to improve oral function, increase blood flow, improve skin quality, reduce stress, improve sleep, and improve immunity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Confirmation of salivary quantity by Saxon test,
Pittsburgh Sleep Quality Index,
Secretory IgA.
Key secondary outcomes
Body temperature when wake up, Body temperature 1hr after bath, Body temperature before going to bed, With or without subjective symptom of chill, Blood flow, Skin moisture level, QOL Common Questionnaire.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Taking bath once a day as more than 15 min submerged to the shoulder level in bathtub filled with hot water (below 41 degrees centigrade) which dissolved 4 tablets of test substance. Continue taking bath everyday for 9 days as similar way.
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
1) Female aged between 40 and 70 years old at when they were informed consent.
2) Must be able to bathe once a day during the test period.
3) A person who has received a full explanation of the purpose and content of the test and who understands the test and is able to obtain his or her written consent.
Key exclusion criteria
1)Subjects who are treated by medicine continuously.
2)Subjects who regularly take functional food and/or health food which is expected to improve chilliness, blood-flow or body temperature, skin quality, stress, sleep and immunity.
3)Subjects who have previous and/or current medical history of serious disease in heart, liver, kidney, digestive organ, skin and central nervous system.
4)Subjects who have disease making unconsciousness at seizure, like arrhythmia, anemia, sleep apnea syndrome, epilepsy or diabetes.And subjects who are previous diagnosed as the same disease.
5)Pregnant or possibly pregnant women, or lactating women.
6)Subjects who have extremely irregular food habits. Subjects who have irregular life cycle because midnight-work or shift-work.
7)Subjects who are participating in the other clinical tests. Subjects who participated within 4 weeks prior to the current study and/or who plan to participate in the other clinical tests.
8)Subjects who have had skin symptoms such as itching and eczema, using bath additives in the past.
9)Subjects who have been judged as unsuitable for the study by the principal investigator or sub-investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Saito |
Organization
Tsurumi University
Division name
Department of Pathology, School of Dental Medicine
Zip code
230-8501
Address
2-1-3,Tsurumi,Tsurumi-ku,Yokohama,Kanagawa,230-0063,Japan
TEL
045-580-8362
saito-i@tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | Mie |
| Middle name | |
| Last name | Kaneko |
Organization
Chiyoda Oralhealth Care Clinic
Division name
None.
Zip code
101-0061
Address
Suidobashi Nishiguchi Kaikan 3F, 2-20-7 Kanda-Misaki-cho, Chiyoda-ku, Tokyo, 101-0061, Japan
TEL
03-3288-8801
Homepage URL
info@cocc.jp
Sponsor or person
Institute
Chiyoda Oralhealth Care Clinic
Institute
Department
Personal name
Funding Source
Organization
HOT ALBUM Tansansen Tablet, Inc.
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.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
| 2020 | Year | 10 | Month | 22 | 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
4
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
| 2020 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 21 | Day |
Last modified on
| 2021 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048028
