UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040490 |
|---|---|
| Receipt number | R000045914 |
| Scientific Title | Effects of Fermented Kochi Golden Ginger Powder and Kochi Red Ginger Powder on Skin Surface Temperature |
| Date of disclosure of the study information | 2021/05/15 |
| Last modified on | 2020/11/11 10:20:22 |
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Basic information
Public title
Effects of Fermented Kochi Golden Ginger Powder and Kochi Red Ginger Powder on Skin Surface Temperature
Acronym
Effects of Fermented Kochi Golden Ginger Powder and Kochi Red Ginger Powder on Skin Surface Temperature
Scientific Title
Effects of Fermented Kochi Golden Ginger Powder and Kochi Red Ginger Powder on Skin Surface Temperature
Scientific Title:Acronym
Effects of Fermented Kochi Golden Ginger Powder and Kochi Red Ginger Powder on Skin Surface Temperature
Region
| Japan |
Condition
Condition
N/A (healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the effects of the test food on peripheral blood flow and skin surface temperature.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Peripheral blood flow and skin surface temperature
Key secondary outcomes
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
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake the test food 1 for 1 week
Interventions/Control_2
Intake the test food 2 for 1 week
Interventions/Control_3
Intake the control food for 1 week
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 Japanese females aged 20-64 years
2)Those who are sensitive to cold
3)Those whose written informed consent has been obtained
Key exclusion criteria
1)Those who have a history of diabetes, liver disease, kidney disease, digestive system disease, heart disease, or other diseases that may affect the results of this test, or who have had a history of surgery
2)Those with abnormal liver and renal function test values
3)Those who have a disease currently being treated
4)Those with food and drug allergies
5)Those who play intense sports and who are on a diet
6)Those who routinely use internal medicines (including foods and supplements) and skin medicines (applications, patches, sprays, etc.) that are expected to have health-promoting effects on skin tissues and blood / vascular functions
7)Those who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and designated quasi-drugs during the test period
8)Those who continuously take medicines (including OTC and prescription medicines)
9)Those who routinely perform various therapies (esthetic treatment, massage, etc.) that are expected to have health-promoting effects on skin tissue and blood / vascular functions
10)Those with a marked abnormality in the skin condition at the test site or those with chronic skin symptoms such as atopic dermatitis
11)Heavy drinkers, or those who can't stop drinking from the day before the test until the day
12)Those with irregular life patterns and with lifestyle of reversal of day and night
13)Those who have habits of excessive eating and drinking
14)Those who have been pregnant or those who have a plan to become pregnant or breast feed during the study period
15)Those who are participating in or will be participating in other clinical trials at the start of this study, and those within 4 weeks after the end
16)Those who judged that examination responsible doctor is not appropriate for this study participation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Shiojima |
Organization
Ryusendo Co., Ltd.
Division name
President and CEO
Zip code
171-0021
Address
1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan
TEL
03-3985-8346
y.shiojima@ryusendo.co.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Takahashi |
Organization
Ryusendo Co., Ltd.
Division name
Development Division
Zip code
171-0021
Address
1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan
TEL
03-3985-8346
Homepage URL
m.takahashi@ryusendo.co.jp
Sponsor or person
Institute
Oneness support Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ryusendo Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Sakata Nobuo Corporation
Ishokukenbi Co., Ltd.
IRB Contact (For public release)
Organization
Miura Clinic, Medical Corporation Kanonkai IRB
Address
9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka 530-0044, Japan
Tel
06-6135-5200
mterashima@miura-cl.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 | 05 | Month | 15 | 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
| 2020 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 22 | Day |
Last modified on
| 2020 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045914
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