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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034572
Receipt No. R000039414
Scientific Title The efficacy test of oral stimuli on salivary secretion
Date of disclosure of the study information 2018/10/26
Last modified on 2019/04/24

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Basic information
Public title The efficacy test of oral stimuli on salivary secretion
Acronym The efficacy test of oral stimuli on salivary secretion
Scientific Title The efficacy test of oral stimuli on salivary secretion
Scientific Title:Acronym The efficacy test of oral stimuli on salivary secretion
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of oral stimuli on salivary secretion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Salivary secretion volume
Key secondary outcomes Salivary secretion rate

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is 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 Single ingestion of the product.
More than 24 hours washout between the ingestions.
Ingestion order: product 1, product 2, product3, product4, product5.
Interventions/Control_2 Single ingestion of the product.
More than 24 hours washout between the ingestions.
Ingestion order: product 2, product 3, product1, product5, product4.
Interventions/Control_3 Single ingestion of the product.
More than 24 hours washout between the ingestions.
Ingestion order: product 3, product 1, product2, product4, product5.
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 Male
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) Subjects with low salivary secretion.
4) Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Yamamoto
Organization Kao Corporation
Division name 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 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
Institute Kao Corporation
Institute
Department

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 10 Month 26 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
2018 Year 07 Month 20 Day
Date of IRB
2018 Year 07 Month 20 Day
Anticipated trial start date
2018 Year 10 Month 31 Day
Last follow-up date
2019 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 19 Day
Last modified on
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039414

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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