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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040490
Receipt No. 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

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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
Email 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
Email m.takahashi@ryusendo.co.jp

Sponsor
Institute Oneness support Co., Ltd.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045914

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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