UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A questionnaire usability survey of SNR11 in premenopausal healthy women
Title of the study (Brief title)	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	Mitsuhiro Sugimoto
Organization	Tohto Bunkyo Hospital
Division name	The director
Address	3-5-7 Yushima, Bunkyo-ku, Tokyo
TEL	03-3831-2181
Email	info@tes-h.co.jp

Public contact
Name of contact person	Ryoma Shimizu
Organization	TES Holdings CO., Ltd.
Division name	Clinical research
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 04 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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