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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039314
Receipt No. R000044827
Scientific Title Study on improvement of coldness by ingestion of black ginger supplement
Date of disclosure of the study information 2020/02/08
Last modified on 2020/01/30

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Basic information
Public title Study on improvement of coldness by ingestion of black ginger supplement
Acronym Improvement of coldness by black ginger supplement
Scientific Title Study on improvement of coldness by ingestion of black ginger supplement
Scientific Title:Acronym Study on improvement of coldness by ingestion of black ginger supplement
Region
Japan

Condition
Condition coldness
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of ingestion of black ginger supplement on improvement of coldness
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes coldness
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 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 The subjects ingested the placebo meal,and ingested the active meal after 7days.
Interventions/Control_2 The subjects ingested the active meal,and ingested the placebo meal after 7days.
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Healthy male and female between 20 and 80 years old
2) Individuals who has subjective symptoms of coldness
3) Individuals who can refrain from over drinking and over eating during the test period
4) Individuals who understand the purpose and contents of the experiment
Key exclusion criteria 1)Subjects who are contracting or treating severe diabetes and kidney and/or liver diseases
2)Individuals who have a chronic diseases and regularly use drugs
3)Pregnant women, or women with intending to become pregnant, and lactating woman
4)Individuals participating or intending to participate in a drug administration test
5)Individuals judged by the doctor to be unsuitable
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Kazunari
Middle name
Last name Tanaka
Organization Univercity of Nagasaki
Division name Faculty of Nursing and Nutrition
Zip code 8512195
Address 1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL 0958135216
Email katanaka@sun.ac.jp

Public contact
Name of contact person
1st name Hideki
Middle name
Last name Ito
Organization Univercity of Nagasaki
Division name Regional Collaboration Center
Zip code 8512195
Address 1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL 0958135216
Homepage URL
Email katanaka@sun.ac.jp

Sponsor
Institute Univercity of Nagasaki
Institute
Department

Funding Source
Organization charle 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 Univercity of Nagasaki
Address 1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
Tel 0958135216
Email katanaka@sun.ac.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 08 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 20
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 No longer recruiting
Date of protocol fixation
2020 Year 01 Month 11 Day
Date of IRB
2019 Year 12 Month 16 Day
Anticipated trial start date
2020 Year 01 Month 11 Day
Last follow-up date
2020 Year 02 Month 16 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 01 Month 30 Day
Last modified on
2020 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044827

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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