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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026027
Receipt No. R000029917
Scientific Title The effect verification examination by continuous use of bath additives
Date of disclosure of the study information 2017/03/01
Last modified on 2017/07/18

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Basic information
Public title The effect verification examination by continuous use of bath additives
Acronym The continuous use examination of bath additives
Scientific Title The effect verification examination by continuous use of bath additives
Scientific Title:Acronym The continuous use examination of bath additives
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test soothing effect from fatigue by continuous use of bath additives
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of fatigue, sleep, body composition, an autonomic nerve function, a vascular function, and blood composition before use of bath additives and after continuous use for 2 and 4 weeks
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Bathe with bath additives A for 10 minutes once a day for 4 weeks
Interventions/Control_2 Bathe with bath additives B for 10 minutes once a day for 4 weeks
Interventions/Control_3 Bathe with bath additives C for 10 minutes once a day for 4 weeks
Interventions/Control_4 Bathe with tap water for 10 minutes once a day for 4 weeks
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
49 years-old >=
Gender Female
Key inclusion criteria Healthy females
Key exclusion criteria (1) Subjects who has a cutaneous symptom which affects the final examination in the body
(2) Subjects who are using the drugs which may influence an examination
(3) Subjects (except for dental care) under a therapy or going to hospital regularly due to sick.
(4) Subjects who has pollinosis
(5) Subjects past menopause
(6) Subjects under pregnancy or who may have been conceived, and breast-feeding
(7) Subjects who has participated in other clinical trials
(8) Subjects judged that a test implementation person in charge is unsuitable
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunori Takashima
Organization INFORWARD inc.
Division name EBISU Skin research center
Zip code
Address 1-11-2 5F, Ebisu Shibuya-ku, Tokyo, 150-0013, JAPAN
TEL 03-5793-8712
Email takashima@inforward.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunori Takashima
Organization INFORWARD inc.
Division name EBISU Skin research center
Zip code
Address 1-11-2 5F, Ebisu Shibuya-ku, Tokyo, 150-0013, JAPAN
TEL 03-5793-8712
Homepage URL
Email takashima@inforward.co.jp

Sponsor
Institute INFORWARD inc.
EBISU Skin research center
Institute
Department

Funding Source
Organization Kao Corporation
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 株式会社インフォワード恵比寿スキンリサーチセンター(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 01 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 01 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 07 Month 18 Day

Other
Other related information

Management information
Registered date
2017 Year 02 Month 07 Day
Last modified on
2017 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029917

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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