UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A confirmation test for the reising effect of body temperature using test sample.
Title of the study (Brief title)	A confirmation test for the reising effect of body temperature using test sample.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Kazuhiro Kobayashi
Organization	HOT ALBUM Tansansen Tablet, Inc.
Division name	Department of Technological Planning
Address	3F Grandehights, 1-10 Higashi-cho, Hachioji-city, Tokyo 192-0082, JAPAN
TEL	042-649-3480
Email	kobayashi@hacom.jp

Public contact
Name of contact person	Masanori Numa
Organization	CPCC Company Limited
Division name	Planning & Sales Department
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

Sponsor
Institute	CPCC Company Limited
Institute
Department

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)

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	2018 Year 06 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 01 Month 27 Day
Last modified on	2018 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035430