UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the effect of ginger extract powder on blood flow rate in healthy subjects
Acronym	Evaluation of the effect of ginger extract powder on blood flow rate in healthy subjects
Scientific Title	Evaluation of the effect of ginger extract powder on blood flow rate in healthy subjects
Scientific Title:Acronym	Evaluation of the effect of ginger extract powder on blood flow rate in healthy subjects
Region	Japan

Condition
Condition	Healthy
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effect of ginger extract powder on retinal blood flow
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	8-week change in retinal blood flow
Key secondary outcomes	>8-week changes in the followings: muscle hardness in shoulder, peripheral blood flow rate, visual analogue scales (VAS) for visual fatigue, VAS for shoulder stiffness, VAS for warmth of a body, dioptometry, radius of curvature of the cornea, central corneal thickness, visual acuity, intraocular pressure, and a fundus photo >The relationship among retinal blood flow, intraocular pressure, and eye stiffness

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Subjects take 1 capsule per day containing 100 mg of ginger extract powder for 8 weeks.
Interventions/Control_2	Subjects take 1 placebo capsule per day for 8 weeks.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Healthy 2) Feeling visual fatigue and shoulder stiffness
Key exclusion criteria	1) Ocular disorder requiring prompt treatment 2) Taking medicines or functional food that may affect the trial 3) Participation in any clinical trial within 90 days of the commencement of the trial 4) In pregnancy or nursing a child 5) Judged as ineligible by the investigators
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Fumiko Middle name Last name Higashikawa
Organization	Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name	Department of Probiotic Science for Preventive Medicine
Zip code	734-8551
Address	Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL	0822571533
Email	fumiko@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Fumiko Middle name Last name Higashikawa
Organization	Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name	Department of Probiotic Science for Preventive Medicine
Zip code	734-8551
Address	Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL	0822571533
Homepage URL
Email	fumiko@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	IKEDA FOOD RESEARCH 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	Ethical Committee for Clinical Research of Hiroshima University
Address	Kasumi 1-2-3 Minami-Ku, Hiroshima 734-8551
Tel	082-257-1551
Email	iryo-seisaku@office.hiroshima-u.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	広島大学病院（広島県）

Other administrative information
Date of disclosure of the study information	2021 Year 07 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	Completed
Date of protocol fixation	2021 Year 07 Month 20 Day
Date of IRB	2021 Year 07 Month 20 Day
Anticipated trial start date	2021 Year 07 Month 28 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 07 Month 28 Day
Last modified on	2022 Year 07 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050968