UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024572 |
|---|---|
| Receipt number | R000028279 |
| Scientific Title | Pre-examination: Effect on oral environment of the plant extract |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2017/05/10 21:32:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Pre-examination: Effect on oral environment of the plant extract
Acronym
Pre-examination: Effect on oral environment of the plant extract
Scientific Title
Pre-examination: Effect on oral environment of the plant extract
Scientific Title:Acronym
Pre-examination: Effect on oral environment of the plant extract
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect on salivary secretion of the plant extract
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of amount of salivary secretion before and after single ingestion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Plant extract beverage, Intake period: 1 day (1 time) --> Plant extract-free beverage, Intake period: 1 day (1 time)
Interventions/Control_2
Plant extract-free beverage, Intake period: 1 day (1 time) --> Plant extract beverage, Intake period: 1 day (1 time)
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Men and women over the age of 65
(2) Those who can measure the volume of saliva
(3) Those who get a detailed briefing on this project in advance, can understand the contents, agree with its purpose, and can submit a written consent
Key exclusion criteria
(1) Those who cannot come to the institution at the day of examination
(2) Those who are doing other examination
(3) Those who take continuous medical treatment
(4) Those who are suffering from such diseases as a heart disease, a liver disease, a kidney disease (including other complications) or have history of circulatory diseases or developed diabetes
(5) Those who are judged as inadequate to participate in this study by doctors in charge
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Zeida |
Organization
Suntory Global Innovation Center Limited
Division name
Research Institute
Zip code
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto
TEL
050-3182-0464
Mitsuhiro_Zeida@suntory.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumi Sasanuma |
Organization
Suntory Global Innovation Center Limited
Division name
Research Institute
Zip code
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto
TEL
070-2288-1140
Homepage URL
Yumi_Ando@suntory.co.jp
Sponsor or person
Institute
Suntory Global Innovation Center Limited
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 11 | Month | 01 | 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 | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | 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
| 2016 | Year | 10 | Month | 26 | Day |
Last modified on
| 2017 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028279
