UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028182 |
|---|---|
| Receipt number | R000032253 |
| Scientific Title | The verification study for improving the blood flow: A randomized double-blind placebo-controlled trial |
| Date of disclosure of the study information | 2017/07/11 |
| Last modified on | 2018/07/05 12:15:53 |
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Basic information
Public title
The verification study for improving the blood flow: A randomized double-blind placebo-controlled trial
Acronym
The verification study for improving the blood flow
Scientific Title
The verification study for improving the blood flow: A randomized double-blind placebo-controlled trial
Scientific Title:Acronym
The verification study for improving the blood flow
Region
| Japan |
Condition
Condition
Healthy Japanese adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of the test food on improving the blood flow
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood flow inspection
1. Blood fluidity (MC-FAN)
2. Conditions of the capillaries (Bscan-Z)
*1,2 Assess at 0 and 4 weeks after consuming
Key secondary outcomes
Questionnaire of subjective symptoms (The Likert scale method)
* Assess at 0 and 4 weeks after consuming
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 4 weeks
Test materials: Wild herb fermented liquid
Administration: Drink a cup of the beverage with a dosing cup (25 mL), once a day at optional timing
* Daily dose must be taken within the day. If you forget drinking the beverage, drink it as soon as you remember within the day.
Interventions/Control_2
Duration: 4 weeks
Test materials: Placebo
Administration: Drink a cup of the beverage with a dosing cup (25 mL), once a day at optional timing
* Daily dose must be taken within the day. If you forget drinking the beverage, drink it as soon as you remember within the day.
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese adults
2. Those who are anxious about the results of the recent medical checkup (the values of HbA1c and blood pressure are rather high)
3. Those who are considered as appropriate for the study by the physician
4. Those whose blood fluidity score (smoothness) is "2: caution" or "3: unusual" at screening and examination before ingestion
5. Among the people who passed 4., select those whose blood flow velocity is relatively slow at screening and examination before ingestion
Key exclusion criteria
1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction
2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, or other chronic diseases
3. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily
4. Currently taking medicines (include herbal medicines) and supplements
5. Those who are allergic to medicines and/or the test food related products
6. Those who have terrible anemia (including currently under the treatment of anemia)
7. Those who drink alcoholic beverages to excess {Average amount of alcohol intake is approximately 60 g per day converted into absolute alcohol (approximately 540 mL of Japanese sake, 3 cans (500 mL / can) of beer, or 300 mL of distilled spirits) }
8. Those who habitually apply medicines to their hands (except for external medicine, moisturizer, and sunscreen)
9. Smokers
10. Those who are chipping off the cuticle on fingernails
11. Those who are pregnant, breast-feeding, and plan to become a pregnant
12. Those who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial
13. Others considered as inappropriate for the study by the physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
YASOUKOUSO .Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Seishin-kai Medical Association Inc, Takara Medical Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
医療法人社団 盛心会 タカラクリニック (東京都)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Kanai T, Suzuki N, Yamashita S, Takara T. Effects of the Fermented Plant Extract YASOUKOUSO on Blood Flow Rate in Humans-A Randomized, Double-blind, Placebo-controlled Parallel-group Study-. Jpn Pharmacol Ther 2018; 46(6): 1005-1012
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 | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 12 | 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
| 2017 | Year | 07 | Month | 11 | Day |
Last modified on
| 2018 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032253
