UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031292 |
|---|---|
| Receipt number | 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 | 2024/05/07 09:01:02 |
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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
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
hisajima@thu.ac.jp
Sponsor or person
Institute
Faculty of Health Care, Teikyo Heisei University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 05 | Day |
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
| 2024 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035322
