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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038331
Receipt No. R000043685
Scientific Title Exploration Study for effect on urinary 8-OHdG level and vascular endothelial function change by ingestion of supplement containing Ginkgo leaf extract for 4 weeks
Date of disclosure of the study information 2019/10/18
Last modified on 2020/03/04

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Basic information
Public title Exploration Study for effect on urinary 8-OHdG level and vascular endothelial function change by ingestion of supplement containing Ginkgo leaf extract for 4 weeks
Acronym Study for effect by ingestion of supplements containing Ginkgo leaf extract
Scientific Title Exploration Study for effect on urinary 8-OHdG level and vascular endothelial function change by ingestion of supplement containing Ginkgo leaf extract for 4 weeks
Scientific Title:Acronym Study for effect by ingestion of supplements containing Ginkgo leaf extract
Region
Japan

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

Objectives
Narrative objectives1 To investigate effect on urinary 8-OHdG level and vascular endothelial function change by ingestion of supplements containing Ginkgo leaf extract 4 weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Urinary 8-OHdG level by ingestion of supplements containing Ginkgo leaf extract before and after 4 weeks
Key secondary outcomes Vascular endothelial function level by ingestion of supplements containing Ginkgo leaf extract before and after 2weeks, and 4weeks ingesting

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 To take Supplements containing Ginkgo leaf extract for 4 weeks.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Persons who are over 20 years old at the time of consent acquisition
3. Persons who are able to keep a record of supplements ingestion by LINE
Key exclusion criteria 1. Persons who are allergic to raw materials of the test food
2. Persons who are taking Antiplatelet drugs, Anticoagulant (Warfarin, Aspirin and so on) Antidepressant and/or Antiepileptic drugs
3. Persons who are planning to take the other new dietary supplements during the exam
4. Persons who are pregnant, breast-feeding and are hoping pregnancy during the exam
5. Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
6. Persons who were judged as inappropriate for subjects by the principal investigator
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Takanori
Middle name
Last name Yasutake
Organization Healthcare Systems Co., Ltd.
Division name Sales Planning Department
Zip code 105-0004
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 03-6809-2722
Email yasutake@hc-sys.jp

Public contact
Name of contact person
1st name Takanori
Middle name
Last name Yasutake
Organization Healthcare Systems Co., Ltd.
Division name Sales Planning Department
Zip code 105-0004
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 03-6809-2722
Homepage URL
Email yasutake@hc-sys.jp

Sponsor
Institute Healthcare Systems Co., Ltd.
Institute
Department

Funding Source
Organization Healthcare Systems Co., Ltd.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Oriduru Group Co., Ltd.
LaView Corp.
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Ethics Committee of Healthcare Systems Co., Ltd.
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel 03-6809-2722
Email kakehashi@hc-sys.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
2019 Year 10 Month 18 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
2019 Year 09 Month 27 Day
Date of IRB
2019 Year 09 Month 27 Day
Anticipated trial start date
2019 Year 10 Month 20 Day
Last follow-up date
2019 Year 12 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
2019 Year 10 Month 18 Day
Last modified on
2020 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043685

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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