UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039180 |
|---|---|
| Receipt number | R000044683 |
| Scientific Title | A study to examine the effects of blood flow improvement and body temperature maintenance effects |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2020/07/18 09:03:37 |
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Basic information
Public title
A study to examine the effects of blood flow improvement and body temperature maintenance effects
Acronym
A study to examine the effects of blood flow improvement and body temperature maintenance effects
Scientific Title
A study to examine the effects of blood flow improvement and body temperature maintenance effects
Scientific Title:Acronym
A study to examine the effects of blood flow improvement and body temperature maintenance effects
Region
| Japan |
Condition
Condition
Healthy Individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify that maintaining body-temperature by improving the blood flow of those who are aware of the cold-constitution.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin surface temperature
Key secondary outcomes
Peripheral blood flow
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test Food A (Tea)
Interventions/Control_2
Oral intake of the test Food B (Extract)
Interventions/Control_3
Oral intake of the test Food C (Tablet)
Interventions/Control_4
Oral intake of the placebo
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
Male and Female
Key inclusion criteria
[1]Males and Females aged 20> years.
[2]Those who are conscious of coldness of 4 points or more (Important item; 2 point, Reference item 1 point) in coldness diagnosis questionnaire
[3] Those whose skin temperature recovery rate is less than 90% after 10 minutes of cold load in skin temperature recovery rate measurement
[4] Those who obtain consent from the document with free will of the subject
Key exclusion criteria
[1]Those who are at risk of developing allergy in connection with research
[2]Those who have been diagnosed as underlying diseases associated with vascular disorders (obstructive arteriosclerosis, obstructive arteritis, collagen disease, diabetes etc.)
[3]Those who were judged inappropriate as subjects from the answers to the questionnaire
[4]Those who have a smoking habit
[5]Those who regularly use prescribed medicines (eg, warfarin, etc.) that may affect blood flow and skin surface temperature
[6]Those who take foods for specified health use or health foods that affect blood flow and skin surface temperature for three days or more per week
[7]Those already taking citrus drinks such as shikuwasa and oranges more than 3 days a week
[8]Those who were judged to have problems with research participation due to abnormalities in clinical laboratory values or cardiorespiratory functions
[9]Those who have a disease requiring continuous medication, those who have had a serious medical history requiring medication therapy
[10]Persons whose values of physical measurement values, physical examination values and clinical laboratory values before the start of ingestion are significantly deviated from the reference range
[11]Those who participate in other clinical research at the start of this research
[12]Others who judged that the researcher is inappropriate as the subject
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Kondo |
| Middle name | |
| Last name | Sumio |
Organization
Medicial Corporation Kenshokai
Division name
Fukushima Healthcare Center
Zip code
553-0004
Address
Tamagawa 2-12-16, Fukushima-ku, Osaka-shi, Osaka, 553-0004, Japan
TEL
06-6441-6848
rtakeda@tamateyama.ac.jp
Public contact
Name of contact person
| 1st name | Takeda |
| Middle name | Takeda |
| Last name | Ryuji |
Organization
Kansai University of Welfare Sciences
Division name
Department of Nutritional Sciences for Well-being
Zip code
582-0026
Address
Asahigaoka 3-11-1, Kashiwara-cuty
TEL
072-978-0088
Homepage URL
rtakeda@tamateyama.ac.jp
Sponsor or person
Institute
Medicial Corporation Kenshokai, Fukushima Healthcare Center
Institute
Department
Personal name
Funding Source
Organization
Musashino Rsearch Institute for Immunity 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
Brain Care Clinic Ethics Review Committee
Address
Samon-Cho13, Isobe Build. 2F, Shinjyuku-ku, Tokyo
Tel
03-3351-3386
yuyosei@drc-web.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
| 2020 | Year | 02 | Month | 01 | 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
| 2019 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 18 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 17 | Day |
Last modified on
| 2020 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044683
