UMIN-CTR Clinical Trial

Basic information
Public title	Verification of changes over time in the intake of the medicinal food "ginger" and skin surface temperature
Acronym	Verification of changes over time in the intake of the medicinal food "ginger" and skin surface temperature
Scientific Title	Verification of changes over time in the intake of the medicinal food "ginger" and skin surface temperature
Scientific Title:Acronym	Verification of changes over time in the intake of the medicinal food "ginger" and skin surface temperature
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verification of the effect of ginger consumption on increasing body temperature.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin surface temperature measurement
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food
Interventions/Control_1	Take grated ginger.
Interventions/Control_2
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	30 years-old >
Gender	Male and Female
Key inclusion criteria	Students affiliated with the Josai University Faculty of Pharmaceutical Sciences
Key exclusion criteria	Those with no food allergies.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Masahiro Middle name Last name Wada
Organization	Josai University
Division name	pharmaceutical sciences
Zip code	3500295
Address	1-1 Keyakidai, Sakado City, Saitama Prefecture
TEL	049-271-7249
Email	mwada@josai.ac.jp

Public contact
Name of contact person	1st name Sanae Middle name Last name Yamada
Organization	Josai University
Division name	pharmaceutical sciences
Zip code	350295
Address	1-1 Keyakidai, Sakado City, Saitama Prefecture
TEL	049-271-7643
Homepage URL
Email	yamada@josai.ac.jp

Sponsor
Institute	Josai University
Institute
Department

Funding Source
Organization	Josai University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Josai University
Address	1-1 Keyakidai, Sakado City, Saitama Prefecture
Tel	049-271-7735
Email	jikken@stf.josai.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	2022 Year 06 Month 28 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	Preinitiation
Date of protocol fixation	2022 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date	2022 Year 07 Month 01 Day
Last follow-up date	2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 06 Month 27 Day
Last modified on	2022 Year 06 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054904