UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027363 |
|---|---|
| Receipt number | 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 11:49:02 |
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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
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
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings CO., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031358
