UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038862 |
|---|---|
| Receipt number | R000044317 |
| Scientific Title | The effect of tea beverage intake on the incidence of acute upper respiratory tract inflammation |
| Date of disclosure of the study information | 2020/11/08 |
| Last modified on | 2022/07/07 11:01:35 |
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Basic information
Public title
The effect of tea beverage intake on the incidence of acute upper respiratory tract inflammation
Acronym
The effect of tea beverage intake on the incidence of acute upper respiratory tract inflammation
Scientific Title
The effect of tea beverage intake on the incidence of acute upper respiratory tract inflammation
Scientific Title:Acronym
The effect of tea beverage intake on the incidence of 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 verify the inhibitive effect on acute upper respiratory tract inflammation by consumption of test food for 12 continuous weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of upper respiratory tract inflammation symptoms (including influenza) during test period
Key secondary outcomes
1. The days until onset of acute upper respiratory tract inflammation from intervention start
2. The days to recovery from acute upper respiratory tract inflammation
3. The frequency of occurrence of acute upper respiratory tract inflammation symptoms for the term of intervention
4. The occurrence of influenza infection by clinical diagnosis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intervention period: 12 weeks
Tea beverage A taken 3 times/day
Interventions/Control_2
Intervention period: 12 weeks
Tea beverage B taken 3 times/day
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. male and female ages 20 over
2. Subjects who show understanding of the clinical study procedures and agreement with participating the study by written informed consent.
Key exclusion criteria
1. Subjects who caught the flu in the period from 8 months prior to the date of consent up until 24 hours before the start of the study
2. Subjects who had a flu vaccine within eight months prior to the date of consent
3. Subjects who have an allergy to tea (green tea, black tea, oolong tea, barley tea and others)
4. Subjects who have severe disease in digestive organs, heart, lungs, liver, kidneys, respiratory organs
5. Pregnant or expected pregnant, or lactating women
6. Others who have been determined ineligible by investigator
7. Those who do not comply with the test plan
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Shinsaku |
| Middle name | |
| Last name | Nakagawa |
Organization
Osaka University
Division name
Graduate School of Pharmaceutical Sciences
Zip code
565-0871
Address
1-6 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-8175
nakagawa@phs.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinsaku |
| Middle name | |
| Last name | Nakagawa |
Organization
Osaka University
Division name
Graduate School of Pharmaceutical Sciences
Zip code
565-0871
Address
1-6 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-8175
Homepage URL
http://www.phs.osaka-u.ac.jp/outline/publicity.html
nakagawa@phs.osaka-u.ac.jp
Sponsor or person
Institute
Graduate School of Pharmaceutical Sciences, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Mitsui Norin Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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
| 2020 | Year | 11 | Month | 08 | 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
75
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
| 2019 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 05 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 12 | Day |
Last modified on
| 2022 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044317
