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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028182
Receipt No. 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

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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
Email 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
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032253

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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