UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030103 |
|---|---|
| Receipt number | R000034373 |
| Scientific Title | The effects of green tea-derived components on acute upper respiratory tract inflammation for health care workers; single-blinded randomized parallel-group trial |
| Date of disclosure of the study information | 2017/11/30 |
| Last modified on | 2021/08/10 21:28:59 |
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Basic information
Public title
The effects of green tea-derived components on acute upper respiratory tract inflammation for health care workers; single-blinded randomized parallel-group trial
Acronym
The effects of green tea-derived components on acute upper respiratory tract inflammation
Scientific Title
The effects of green tea-derived components on acute upper respiratory tract inflammation for health care workers; single-blinded randomized parallel-group trial
Scientific Title:Acronym
The effects of green tea-derived components on acute upper respiratory tract inflammation
Region
| Japan |
Condition
Condition
Acute upper respiratory tract inflammation
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of green tea-derived components on the development of acute upper respiratory tract inflammation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The occurrence of acute upper respiratory tract inflammation (including influenza).
Key secondary outcomes
1. Incidence of influenza like illness.
2. Frequency of acute upper respiratory tract inflammation (including influenza).
3. Adverse events.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
12 weeks,
Placebo drink,
once a day
Interventions/Control_2
12 weeks,
Active drink, including green tea-derived components,
once a day
Interventions/Control_3
12 weeks,
Active drink, including green tea-derived components,
three times a day
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) The male and female employees aged 20 or over but under 75 who work in medical and welfare facilities
(2) Able to give written informed consent
(3) Able to intake tea catechins
(4) Able to write questionnaire
Key exclusion criteria
(1) Potentially having the allergy to tea-derived components
(2) Having severe systemic chronic infectious diseases
(3) Being difficulty to participate the study due to having severe hepatic/renal/ cardiac/respiratory/endocrinological/metabolic disorder, neurological and consciousness disorder, diabetes and other illnesses
(4) Having severe immune deficiency or autoimmune disease, or taking drugs influencing immune functions (e.g. steroid, immunosuppressive drugs, and so on)
(5) Not able to stop health products or supplements that potentially influence immune functions
(6) Going to participate any clinical trial
other than this study
(7) Subjects diagnosed by physicians inappropriate to participate in the study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yamada |
Organization
University of Shizuoka
Division name
School of Pharmaceutical Sciences
Zip code
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL
+81-54-264-5762
hyamada@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yamada |
Organization
University of Shizuoka
Division name
School of Pharmaceutical Sciences
Zip code
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL
+81-54-264-5762
Homepage URL
http://u-shizuoka-ken.ac.jp
hyamada@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
(1) White Cross Nursing Home
(2) Tokyo White Cross Hospital
(3) Tokyo-Bannan-Hakkoen
(4) Kao-Corporation
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
| 2017 | Year | 11 | Month | 30 | 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
| 2017 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 15 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 24 | Day |
Last modified on
| 2021 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034373
