UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031053
Receipt number R000035459
Scientific Title The efficacy test of KTT002
Date of disclosure of the study information 2018/01/30
Last modified on 2019/02/07 13:50:36

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Basic information

Public title

The efficacy test of KTT002

Acronym

The efficacy test of KTT002

Scientific Title

The efficacy test of KTT002

Scientific Title:Acronym

The efficacy test of KTT002

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Medicine in general Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of KTT002 for physical conditions and symptoms.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Questionnaire about physical conditions and symptoms before and after 8wks sample ingestion.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of active three times a day for 8 weeks.

Interventions/Control_2

Ingestion of control three times a day for 8 weeks.

Interventions/Control_3

Observation group

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

60 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy subjects giving written informed consent.

Key exclusion criteria

1) Subjects with a history of allergy or might be liable to allergy related to the study
2) Subjects who have serious historical disease, marked impairment, or treatment in the liver, kidney, heart, lung, gastrointestinal tract, blood, endocrine system, or metabolism system
3) The pregnant and subjects who hope to get pregnant during the exam period
4) Subjects who are ineligible due to life-style questionnaire
5) Subjects deemed inappropriate to participate in this study by the principle investigator.

Target sample size

345


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinji Yamamoto

Organization

Kao Corporation

Division name

R&D-Development Research-Personal Health Care Products Research

Zip code


Address

2-1-3, Bunka Sumida-ku Tokyo, 131-8501, JAPAN

TEL

03-5630-9416

Email

yamamoto.shinji@kao.com


Public contact

Name of contact person

1st name
Middle name
Last name Kenkichi Yamamoto

Organization

Kao Corporation

Division name

R&D-Development Research-Personal Health Care Products Research

Zip code


Address

2-1-3, Bunka Sumida-ku Tokyo, 131-8501, JAPAN

TEL

03-5630-9416

Homepage URL


Email

yamamoto.kenkichi@kao.com


Sponsor or person

Institute

Kao Corporation

Institute

Department

Personal name



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(東京都)


Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 30 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

2017 Year 12 Month 15 Day

Date of IRB


Anticipated trial start date

2018 Year 02 Month 01 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

2018 Year 01 Month 29 Day

Last modified on

2019 Year 02 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035459


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name