UMIN-CTR Clinical Trial

Public title

A confirmation test for the reising effect of body temperature using test sample.

Acronym

A confirmation test for the reising effect of body temperature using test sample.

Scientific Title

A confirmation test for the reising effect of body temperature using test sample.

Scientific Title:Acronym

A confirmation test for the reising effect of body temperature using test sample.

Region

Japan

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effects of reising body temperature, decreasing stress and/or improving sleep by means of using test sample.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Body temperature when wake up,
Short Form POMS2 for adults,
Pittsburgh Sleep Quality Index

Key secondary outcomes

Body temperature before lunch,
Body temperature before dinner,
Body temperature before bath,
Body temperature 1hr after bath,
Body temperature before going to bed,
With or without subjective symptom of chill,
Confirmation of salivary quantity by Saxon test,
Oral cavity candida test.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

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 sample. Continue taking bath everyday for 4 weeks as similar way.

Interventions/Control_2

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 placebo sample. Continue taking bath everyday for 4 weeks as similar way.

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

30

years-old

<=

Age-upper limit

59

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Males and females aged 30 to 59 years old at when they were informed consent.
2) Subjects who have subjective symptom of chilliness.
3) Subjects who have self-conscious of low body temperature.
4) Women who are menopause or have stable menstrual cycle, which is 28 to 32 days.
5) Subjects who will be able to take bath once a day during test period.
6) Subjects who are explained about the study, show understanding of the study procedures, and show agreement with participating to the study by written informed consent prior to the study.

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.
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

54

Name of lead principal investigator

1st name
Middle name
Last name	Kazuhiro Kobayashi

Organization

HOT ALBUM Tansansen Tablet, Inc.

Division name

Department of Technological Planning

Zip code

Address

3F Grandehights, 1-10 Higashi-cho, Hachioji-city, Tokyo 192-0082, JAPAN

TEL

042-649-3480

Email

kobayashi@hacom.jp

Name of contact person

1st name
Middle name
Last name	Masanori Numa

Organization

CPCC Company Limited

Division name

Planning & Sales Department

Zip code

Address

4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

TEL

03-5297-3112

Homepage URL

Email

cpcc-contact@cpcc.co.jp

Institute

CPCC Company Limited

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

Address

Tel

Email

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

2018

Year

06

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

12

Month

21

Day

Date of IRB

Anticipated trial start date

2018

Year

01

Month

29

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

01

Month

27

Day

Last modified on

2018

Year

06

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035430