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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031292
Receipt No. R000035322
Scientific Title The clinical study to elucidate the effects of Oligonol and the prescription containing Oligonol on the blood flow and its relative body functions.
Date of disclosure of the study information 2019/05/01
Last modified on 2019/09/09

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Basic information
Public title The clinical study to elucidate the effects of Oligonol and the prescription containing Oligonol on the blood flow and its relative body functions.
Acronym Clinical trial for improvement of blood flow and its relative body functions.
Scientific Title The clinical study to elucidate the effects of Oligonol and the prescription containing Oligonol on the blood flow and its relative body functions.
Scientific Title:Acronym Clinical trial for improvement of blood flow and its relative body functions.
Region
Japan

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

Objectives
Narrative objectives1 The present study aimed to investigate whether Oligonol affects the blood flow and its relative body function in healthy subjects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Blood flow
Key secondary outcomes Cold finger, tension in shoulders, swelling of lower limbs

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 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Placebo
Subjects take two capsules containing dextrin as the placebo every day for 4 weeks.
Interventions/Control_2 Oligonol
Subjects take two capsules containing Oligonol every day for 4 weeks.
Interventions/Control_3 Prescription product
Subjects take two capsules of prescription containing Oligonol every day for 4 weeks.
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
16 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1) person who worries about cold limbs, swelling of lower limb after standing works, tension in shoulder during desk work, and hearing.
2) person who can come to the test place on the day of evaluations.
3) person who diagnosed as health by doctor.
Key exclusion criteria 1) person who ingests drug or supplement to improve the blood flow.
2) person who has chronic diseases and ingests the drugs.
3) heavy smoker (over 21/day)
4) heavy drunker (over 20 g of ethanol/day)
5) person who has the potential of allergy against drugs and foods especially, lychee and green tea.
6) person who are pregnant or expected to be pregnant, or lactating during the study.
7) person who cannot stop excess ingesting of the food containing large amount polyphenol such as green tea or brown tea.
8) person who is judged as ineligible by doctor.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name Tatsuya
Middle name
Last name Hisajima
Organization Teikyo Heisei University
Division name Faculty of Health Care
Zip code 170-8445
Address 2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo.
TEL 03-5843-4860
Email hisajima@thu.ac.jp

Public contact
Name of contact person
1st name Tatsuya
Middle name
Last name Hisajima
Organization Teikyo Heisei University
Division name Faculty of Health Care
Zip code 170-8445
Address 2-51-4, Higashi-ikebukuro, Toshima-ku, Tokyo
TEL 03-5843-4860
Homepage URL
Email hisajima@thu.ac.jp

Sponsor
Institute Faculty of Health Care, Teikyo Heisei University
Institute
Department

Funding Source
Organization Amino Up Chemical 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 Teikyo Heisei University ethic screening committee
Address 2-51-4, Higashi-ikebukuro, Toshima-ku, Tokyo, Japan
Tel 03-5843-3111
Email rec@thu.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
2019 Year 05 Month 01 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 25
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
2017 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 14 Day
Last modified on
2019 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035322

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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