UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024402
Receipt number R000028058
Scientific Title Continued ingestion test of the plant extract containing food.
Date of disclosure of the study information 2016/10/13
Last modified on 2016/10/24 10:46:14

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Basic information

Public title

Continued ingestion test of the plant extract containing food.

Acronym

Continued ingestion test of the plant extract containing food.

Scientific Title

Continued ingestion test of the plant extract containing food.

Scientific Title:Acronym

Continued ingestion test of the plant extract containing food.

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm the complaints of ingesting the plant extract containing food of healthy female.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of Complaints.
(Evaluation time:0,2 and 4weeks after ingestion of the test food.)

Key secondary outcomes

Evaluation of Health Related Quality of Life.
(Evaluation time:0,2 and 4weeks after ingestion of the test food.)


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 once a day for 28days.

Interventions/Control_2

Ingestion of control1 once a day for 28days.

Interventions/Control_3

Ingestion of control2 once a day for 28days.

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

50 years-old <=

Age-upper limit

70 years-old >

Gender

Female

Key inclusion criteria

1)Informed consent provided
2)Aged between50 and 69 women
3)Persons who have had stiffness in a month.

Key exclusion criteria

1)Persons who have possibilities for emerging allergy to foods.
2)Persons who have had rheumatism or disc herniation or collagen diseases or Parkinson's disease.
3)Persons who are considered inappropriate by the investigator or project leader.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasushi Shioya

Organization

Kao Corporation

Division name

Health Care Food Research Labs.

Zip code


Address

2-1-3, bunka, sumida-ku, Tokyo, 131-8501, JAPAN

TEL

03-5630-7251

Email

shioya.yasushi@kao.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Aiko Shudo

Organization

Kao Corporation

Division name

Health Care Food Research Labs.

Zip code


Address

2-1-3, bunka, sumida-ku, Tokyo, 131-8501, JAPAN

TEL

03-5630-7464

Homepage URL


Email

shudou.aiko@kao.co.jp


Sponsor or person

Institute

Macromill,Inc.

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Other

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

被験者自宅


Other administrative information

Date of disclosure of the study information

2016 Year 10 Month 13 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

No longer recruiting

Date of protocol fixation

2016 Year 10 Month 13 Day

Date of IRB


Anticipated trial start date

2016 Year 10 Month 14 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

2016 Year 10 Month 13 Day

Last modified on

2016 Year 10 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028058


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name