UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038455 |
|---|---|
| Receipt number | R000043820 |
| Scientific Title | Observational study of the effects of differences in hands and saliva ingredients on infectious diseases |
| Date of disclosure of the study information | 2019/10/31 |
| Last modified on | 2022/11/16 09:08:15 |
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Basic information
Public title
Observational study of the effects of differences in hands and saliva ingredients on infectious diseases
Acronym
Effects of different ingredients on infectious diseases
Scientific Title
Observational study of the effects of differences in hands and saliva ingredients on infectious diseases
Scientific Title:Acronym
Effects of different ingredients on infectious diseases
Region
| Japan |
Condition
Condition
Healthy human
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of differences in hands and saliva ingredients on infectious diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rate of acute upper respiratory tract infection
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy human
Key exclusion criteria
1, difficult to participate the study due to disorders of liver, kidney, heart, respiration, endocrine, metabolism, nerve, consciousness or diabetes, or the other disorders
2, medications or surgery for a disease or injury within 2 months before the study
3, Subjects who have been to get sick by collecting venous blood
4, the alcohol-intolerant subjects
5, Subjects who have had influenza since June 2019
6, pregnant
7, shift workers
8, attend or entry the other clinical study
9, judged to be inappropriate for the study by the medical doctor
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Misawa |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL
+81-3-5630-7268
misawa.koichi@kao.com
Public contact
Name of contact person
| 1st name | Nami |
| Middle name | |
| Last name | Yamanaka |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL
+81-3-5630-7268
Homepage URL
yamanaka.nami2@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
None
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
Ueno asagao clinic IRB
Address
2-7-5, Higashiueno, Taito-ku, Tokyo, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.co.jp
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
| 2019 | Year | 10 | Month | 31 | Day |
Related information
URL releasing protocol
Unpublished due to the protocol including the intellectual property rights
Publication of results
Unpublished
Result
URL related to results and publications
works in progress
Number of participants that the trial has enrolled
399
Results
In the analysis
Results date posted
| 2021 | Year | 05 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy human
Participant flow
All participants completed the study
Adverse events
No adverse events occurred
Outcome measures
Incidence of infectious diseases
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Recruit period: Oct-Nov,2019
400 people who fulfilled the criteria in the WEB survey were randomly extracted.
blood, saliva, hands ingredients, diary
Management information
Registered date
| 2019 | Year | 10 | Month | 31 | Day |
Last modified on
| 2022 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043820
