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

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 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


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

Value
https://center6.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