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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027363
Receipt No. R000031358
Scientific Title A questionnaire usability survey of SNR11 in premenopausal healthy women
Date of disclosure of the study information 2018/12/31
Last modified on 2017/11/16

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Basic information
Public title A questionnaire usability survey of SNR11 in premenopausal healthy women
Acronym A questionnaire usability survey of SNR11
Scientific Title A questionnaire usability survey of SNR11 in premenopausal healthy women
Scientific Title:Acronym A questionnaire usability survey of SNR11
Region
Japan

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

Objectives
Narrative objectives1 In this study, we investigate the feeling after ingestion of SNR11, a functional food under development, for 7 days by questionnaire in premenopausal healthy women.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Daily feeling during ingestion for 7days
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 SNR11, 1time/day, for 7days
Interventions/Control_2
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
50 years-old >
Gender Female
Key inclusion criteria Premenopausal healthy women with normal menstrual cycle
Key exclusion criteria Individuals who are under medical treatment
Individuals who are allergic to food or medicine
Individuals who are or may be pregnant and nursing women
Individuals who are diagnosed as inappropriate for the trial by the principal Investigator
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiro Sugimoto
Organization Tohto Bunkyo Hospital
Division name The director
Zip code
Address 3-5-7 Yushima, Bunkyo-ku, Tokyo
TEL 03-3831-2181
Email info@tes-h.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryoma Shimizu
Organization TES Holdings CO., Ltd.
Division name Clinical research
Zip code
Address 7-3-1 Hongoh, Bunkyo-ku, Tokyo
TEL 03-6801-8480
Homepage URL
Email r.shimizu@tes-h.co.jp

Sponsor
Institute TES Holdings CO., Ltd.
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Co., Ltd.
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 12 Month 31 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 Open public recruiting
Date of protocol fixation
2017 Year 04 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 16 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
2017 Year 05 Month 16 Day
Last modified on
2017 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031358

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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