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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023443
Receipt No. R000027012
Scientific Title A study on the effectiveness of USRP001(development code)
Date of disclosure of the study information 2016/08/07
Last modified on 2017/04/04

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Basic information
Public title A study on the effectiveness of USRP001(development code)
Acronym A study on the effectiveness of USRP001(development code)
Scientific Title A study on the effectiveness of USRP001(development code)
Scientific Title:Acronym A study on the effectiveness of USRP001(development code)
Region
Japan

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

Objectives
Narrative objectives1 To confirm the effectiveness of USRP001(development code) for the urinary functions
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Subjective and objective indicators on urinary functions before and after the intake of test foods for 4weeks
Key secondary outcomes Subjective and objective indicators on sleep quality, autonomic nervous activity, physical activity and biochemical components in blood and urine before and after the intake of test foods for 4weeks

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 -Intake USRP001(development code) twice a day for 4weeks
-Washout for 4 weeks
-Intake placebo foods twice a day for 4weeks
Interventions/Control_2 -Intake placebo foods twice a day for 4weeks
-Washout for 4 weeks
-Intake USRP001(development code) twice a day for 4weeks
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
20 years-old <=
Age-upper limit
59 years-old >=
Gender Male
Key inclusion criteria Healthy males
Key exclusion criteria 1.Subjects who attend a hospital or who take drugs
2.Subjects who are always under the weather
3.Subjects who underwent the surgery of urinary functions
4.Subjects who have had brain spinal cord injury, cystitis, vesicoureteral reflux, ureteral stone, prostatitis, urethritis or prostatic hyperplasia
5.Subjects who have had severe diseases
6.Subjects who drink water over 2.5L a day
7.Subjects who cannot intake test foods
8.Subjects who cannot measure EEG, autonomic nervous activity or physical activity
9.Subjects who has allergy to medical tapes or electrodes
10.Subjects who participate in the other examinations which have an influence on this examination
11.Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takatoshi Murase
Organization Kao Corporation
Division name R&D -Core Technology- Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7871
Email murase.takatoshi@kao.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoya Kitamura
Organization Kao Corporation
Division name R&D -Core Technology- Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7458
Homepage URL
Email kitamura.naoya@kao.co.jp

Sponsor
Institute Kao Corporation
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 花王株式会社栃木事業場(栃木県)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 07 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
2016 Year 04 Month 27 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 08 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
2016 Year 08 Month 02 Day
Last modified on
2017 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027012

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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