UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044060 |
|---|---|
| Receipt number | R000050102 |
| Scientific Title | Confirmation research on sleep improvement by ingestion of a black tea ingredient-containing tablet |
| Date of disclosure of the study information | 2022/04/29 |
| Last modified on | 2022/04/22 10:13:17 |
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Basic information
Public title
Confirmation research on sleep improvement by ingestion of a black tea ingredient-containing tablet
Acronym
Confirmation research on sleep improvement by ingestion of a black tea ingredient-containing tablet
Scientific Title
Confirmation research on sleep improvement by ingestion of a black tea ingredient-containing tablet
Scientific Title:Acronym
Confirmation research on sleep improvement by ingestion of a black tea ingredient-containing tablet
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to verify some kind of sleep-improving effect, which could be induced by consumption of a black tea ingredient-containing tablet for two weeks
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. OSA sleep inventory
2. Pittsburg sleep questionnaire
Key secondary outcomes
1. Stress Check List 30
2. Active mass
3. Self-rating Depression Scale
4. Mental age
5. Brain execution
6. Chromogranin A
7. Oxytocin
8. sIgA
9. Cortisol
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are 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
Ingestion of the test tablet licking to the subject without chewing, four times a day (every daily meal, and before going to bed, basically).
Interventions/Control_2
Ingestion of the placebo tablet licking to the subject without chewing, four times a day (every daily meal, and before going to bed, basically).
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
| 30 | years-old | <= |
Age-upper limit
| 46 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy male/female subjects ranging in age from 30 to 45, living in Tokyo and the surrounding area.
(2) Subjects spending a sleepless night (difficulty in falling asleep for not less than 30 min, in waking up perspicuously; and having a nocturnal awakening, a lack of sleeping time).
(3) Subjects working for not less than 4 days a week, restricting for not less than 3.5 hours in the daytime.
(4) Subjects who can give informed consent to participate in this trial after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Subjects who do not care for a black tea very much.
(2) Subjects with smoking habit.
(3) Subjects being over-sensitiveness to cold, even during the summer season.
(4) Subjects with nasal congestion during this trial.
(5) At present, subjects with continuous medical treatment.
(6) Subjects having present/previous medical history of serious diseases in liver, kidney, heart, lung, and/or blood.
(7) Subjects with a remedy for their sleep disorder.
(8) Subjects with high blood pressure--max of above 160 mmHg, min of above 100 mmHg--.
(9) Subjects who have any difficulty in refraining from taking steadily in the health-specific/functional/health foods, which might affect their sleep during this trial.
(10) Subjects who realized that the subjects themselves must be in a state of menopausal disorder.
(11) Subjects planning to go on a trip, or to stay in places except homes.
(12) Subjects with any difficulty in refraining from using a smartphone/cellphone/personal computer, an hour before going to bed.
(13) Subjects who have any difficulty in refraining from alcohol and/or caffein, after 17 o'clock during this trial.
(14) Subjects sleeping together with their family (especially in pre-school children) in a bed time.
(15) Pregnant, possibly pregnant, or lactating women.
(16) Subjects donated their blood components and/or whole blood (200 mL) within a month to this trial.
(17) Males donated their whole blood (400 mL) within the last three months to this trial.
(18) Females donated their whole blood (400 mL) within the last four months to this trial.
(19) Males being collected in total of their blood (1200 mL) for the last twelve months plus in this trial.
(20) Females being collected in total of their blood (800 mL) for the last twelve months plus in this trial.
(21) Subjects being under the other clinical tests, or took part in those within a month before this trial.
(22) Others as ineligible for participation, determined by the principal investigator's opinions.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Mitsui Norin Co.,LTD.
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.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
| 2022 | Year | 04 | Month | 29 | 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
| 2021 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 27 | Day |
Last modified on
| 2022 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050102
