UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047429 |
|---|---|
| Receipt number | R000053920 |
| Scientific Title | Validation of effects on blood flow, mental stress and sleep quality by using a test additive |
| Date of disclosure of the study information | 2023/04/13 |
| Last modified on | 2023/06/27 16:55:07 |
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Basic information
Public title
Validation of effects on blood flow, mental stress and sleep quality by using a test additive
Acronym
Validation of effects on blood flow, mental stress and sleep quality by using a test additive
Scientific Title
Validation of effects on blood flow, mental stress and sleep quality by using a test additive
Scientific Title:Acronym
Validation of effects on blood flow, mental stress and sleep quality by using a test additive
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 investigate whether the use of the test additive could have effects on mental stress and sleep quality.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Simplified questionnaire survey about mental stress (simple ver.: 23 questions)
2. Sleeping parameter by activity tracker
3. Pittsburg sleep questionnaire
Key secondary outcomes
1. Test for immunological capacity
2. Neutrophilic phagocytosis
3. NK-cell activity
4. The Profile of Mood States Second Edition (Japanese short ver.)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use of the test additive (4 tablets) once a day, while taking a bath.
Interventions/Control_2
Not using the test additive, while taking a bath.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Male/female subjects ranging in age from 30 to 59 at informed consent.
(2) Subjects fully realized that the subjects themselves must be in a stressful condition.
(3) Subjects who are dissatisfied with their sleep condition.
(4) Women who reached the menopause, or ranging in menstruation from 28 to 32 days steadily.
(5) Subjects who can take a bath once a day, during this trial.
(6) Subjects who can give informed consent to take part in this trial, after being provided with an explanation of our experimental protocol detail.
Key exclusion criteria
(1) Subjects who take steadily in the health-specific/functional/supplementary/health foods which might affect this trial, and will have any difficulty in giving up taking them after the consent.
(2) Subjects who have taken affecting medicines, and have any difficulty in refraining from taking them during this trial.
(3) Subjects having an irregular life rhythm with irregular shift work or midnight one.
(4) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
(5) Pregnant, possibly pregnant, and lactating women.
(6) Subjects having the possibility of unconsciousness induced by arrhythmia, hypertension, orthostatic hypotension, sleep-apnea syndrome, or epileptic/hypoglycemic fit.
(7) Subjects with some kind of skin symptom, just like an itch and a rash, by using a bath additive.
(8) Subjects who are under other clinical trials with some kind of medicine/food, or participated in those within the last four weeks before this trial, or are planning to join those after the consent.
(9) Subjects who donated their blood components and/or whole blood (200 mL) within a month to this trial.
(10) Males who donated their whole blood (400 mL) within the last three months to this trial.
(11) Females who donated their whole blood (400 mL) within the last four months to this trial.
(12) Males who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial.
(13) Females who will be collected in total of their blood (800 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial.
(14) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target sample size
25
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
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
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
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Crane Science Corp.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
HOTTAB. Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
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
| 2023 | Year | 04 | Month | 13 | 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
| 2022 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 07 | Day |
Last modified on
| 2023 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053920
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| Registered date | File name |
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