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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025249
Receipt No. R000029039
Scientific Title A study for the effect of the intake of an aojiru beverage on microflora
Date of disclosure of the study information 2016/12/13
Last modified on 2017/09/07

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Basic information
Public title A study for the effect of the intake of an aojiru beverage on microflora
Acronym A study for the effect of the intake of an aojiru beverage on microflora
Scientific Title A study for the effect of the intake of an aojiru beverage on microflora
Scientific Title:Acronym A study for the effect of the intake of an aojiru beverage on microflora
Region
Japan

Condition
Condition rough skin, dry skin
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The object of this study is to evaluate the mechanism of improvement of skin conditions by aojiru beverage intake.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Measurement of skin conditions (measurement time: 0,4,8 weeks after ingestion of the test bevarage)
Measurement of microflora (measurement time: 0,8 weeks after ingestion of the test bevarage)
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 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingestion of an aojiru bevarage twice a day for 8weeks
Interventions/Control_2 Ingestion of a placebo bevarage twice a day for 8weeks
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

Not applicable
Gender Female
Key inclusion criteria 1.Healthy female 20 years of age or more
2.Subjects who have rough skin by drying or other skin problems
3.Subjects who can make self-judgement and are voluntarily giving written informed consents
4.Subjects who can obey the directions of the investigators
Key exclusion criteria 1.Subjects who take antibiotics within the last two months prior to the current study or who take intestinal drugs daily
2.Subjects who are under treatment by a dermatologist for dry skin, inflammation or other skin diseases. Or difficulty with measuring points by scars or other skin problems
3.Subjects who are serious constipated or contract serious diseases of anus or intestines
4.Subjects who contract diseases which may affect the current study
5.Subjects who are menstrual irregularity (except for menopause)
6.Subjects who take other aojiru, foods which influence intestinal functions, supplements, other specified foods daily, and they are not able to stop during the current study period
7.Subjects who have declared allergic reaction to test foods
8.Subjects who are under treatment for or have a history of drug addiction or alcoholism
9.Subjects who are pregnant or are planning to become pregnant after informed consent for the current study
10.Subjects who are planning to participate and/or are participating in other clinical studies
11.Subjects who are judged as unsuitable for the current study by the investigator for other reasons
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuya Yamaguchi
Organization TOYO SHINYAKU Co., Ltd.
Division name Research Promotion Office
Zip code
Address 7-28 Yayoigaoka,Tosu-Shi,Saga
TEL 0942-81-3555
Email yamaguchik@toyoshinyaku.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobutaka Kusaba
Organization TOYO SHINYAKU Co., Ltd.
Division name Research Promotion Office
Zip code
Address 7-28 Yayoigaoka,Tosu-Shi,Saga
TEL 0942-81-3555
Homepage URL
Email gakujutsu@toyoshinyaku.co.jp

Sponsor
Institute TOYO SHINYAKU Co., Ltd.
Institute
Department

Funding Source
Organization TOYO SHINYAKU 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
2016 Year 12 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 Completed
Date of protocol fixation
2016 Year 12 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 14 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2017 Year 08 Month 10 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 13 Day
Last modified on
2017 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029039

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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