UMIN-CTR Clinical Trial

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

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

saito-i@tsurumi-u.ac.jp

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

Email

info@cocc.jp

Institute

Chiyoda Oralhealth Care Clinic

Institute

Department

Personal name

Organization

HOT ALBUM Tansansen Tablet, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

Email

IRB@cpcc.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

10

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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