UMIN-CTR Clinical Trial

Basic information
Public title	Effect of feeding black ginger supplement on improvement of cold intolerance
Acronym	Improvement of cold intolerance by feeding black ginger supplement
Scientific Title	Effect of feeding black ginger supplement on improvement of cold intolerance
Scientific Title:Acronym	Effect of feeding black ginger supplement on improvement of cold intolerance
Region	Japan

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

Objectives
Narrative objectives1	Investigate the effects of feeding black ginger supplement on improvement of cold tolerance
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin surface temperature of fingers and feet
Key secondary outcomes	Vas questionaire (1)cold intolerance of whole body (2)cold intolerance of limbs (3)fatigue (4)shoulder stiffness (5)quality of sleep (6)constipation

Base
Study type	Interventional

Study design
Basic design	Parallel
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 for 28 days.
Interventions/Control_2	The subjects ingested the active meal for 28 days.
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1) Healthy male and female between 20 and 70 years old 2) Individuals who has subjective symptoms of cold intolerance 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	60

Research contact person
Name of lead principal investigator	1st name Kazunari Middle name Last name Tanaka
Organization	Univercity of Nagasaki
Division name	Regional Partnership Center
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 Partner 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	2021 Year 01 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	60
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	Preinitiation
Date of protocol fixation	2021 Year 01 Month 13 Day
Date of IRB	2020 Year 12 Month 17 Day
Anticipated trial start date	2021 Year 01 Month 13 Day
Last follow-up date	2021 Year 02 Month 28 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 12 Month 16 Day
Last modified on	2020 Year 12 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048801

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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