UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044513 |
|---|---|
| Receipt number | R000050833 |
| Scientific Title | A study for effects on body surface temperature and feeling of "Ninnikushoga" intake under cool conditions in healthy adult female who are concerned about cold. |
| Date of disclosure of the study information | 2021/06/13 |
| Last modified on | 2021/10/29 09:19:03 |
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Basic information
Public title
A study for effects on body surface temperature and feeling of "Ninnikushoga" intake under cool conditions in healthy adult female who are concerned about cold.
Acronym
A study for effects on body surface temperature and feeling of "Ninnikushoga" intake under cool conditions in healthy adult female who are concerned about cold.
Scientific Title
A study for effects on body surface temperature and feeling of "Ninnikushoga" intake under cool conditions in healthy adult female who are concerned about cold.
Scientific Title:Acronym
A study for effects on body surface temperature and feeling of "Ninnikushoga" intake under cool conditions in healthy adult female who are concerned about cold.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects on body surface temperature and feeling of "Ninnikushoga" intake under cool conditions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the curve of body surface temperature
Key secondary outcomes
Body surface temperature
Autonomic function
Subjective symptoms questionnaire
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food (single ingestion) - washing out (a day or more) - intake of placebo (single ingestion)
Interventions/Control_2
Intake of placebo (single ingestion) - washing out (a day or more) - intake of test food (single ingestion)
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
| 64 | years-old | >= |
Gender
Female
Key inclusion criteria
(1)Healthy females from 20 to 64 years of age
(2)Subjects who are aware of getting cold of fingers under air conditioner working
(3)Subjects who live an ordered life
(4)Subjects who drop body surface temperature under cool conditions on preliminary examination
Key exclusion criteria
(1)Subjects who have been diagnosed underlying disease accompanied with angiopathy (e.g. arteriosclerosis obliterans, arteritis obliterans, collagen disease and diabetes, etc.)
(2)Subjects who constantly take medicines affecting the skin surface temperature(e.g. warfarin)
(3)Subjects who eat food for specified health or health food affecting the skin surface temperature(e.g. healthy food including garlic or ginger) at least once a week
(4)Subjects having food allergy
(5)Subjects who are smokers or have smoked within the past 3 months
(6)Subjects who have a scar affecting the skin surface temperature and autonomic function on fingers, palms, toes and insteps
(7)Subjects who have worked shifts day and night or are planned to work shifts day and night from a month before obtaining the consent for this study to the date of the completion this study
(8)Subjects who have gone abroad or are planned to go abroad from a month before obtaining the consent for this study to the date of the completion this study
(9)Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(10)Subjects who intend to become pregnant or lactating during the study
(11)Subjects having a disease requiring treatment or taking medicines
(12)Subjects having a history of serious diseases
(13)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(14)Subjects who are not judged as healthy based on the results of clinical and physical examination on preliminary examination
(15)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Nakasone |
Organization
Kenkoukazoku Co., Ltd.
Division name
None
Zip code
892-0848
Address
10-2, Hirano-cho, Kagoshima-shi, Kagoshima, 892-0848, JAPAN
TEL
099-223-5211
yasushi.nakasone@kenkoukazoku.co.jp
Public contact
Name of contact person
| 1st name | Yoshimi |
| Middle name | |
| Last name | Bansho |
Organization
EP Mediate Co., Ltd.
Division name
Development Business Headquarters, TTC Center, Trial Planning Department
Zip code
162-0822
Address
Tsuruya Bldg.,2-23, Shimomiyabicho, Shinjuku-ku, Tokyo
TEL
03-5657-4983
Homepage URL
bansho189@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kenkoukazoku 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
080-2290-2544
makabe295@eps.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
| 2021 | Year | 06 | 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
| 2021 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 22 | 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 | 06 | Month | 11 | Day |
Last modified on
| 2021 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050833
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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