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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031026
Receipt No. R000035430
Scientific Title A confirmation test for the reising effect of body temperature using test sample.
Date of disclosure of the study information 2018/06/29
Last modified on 2018/06/27

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Basic information
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
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
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

Public contact
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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