UMIN-CTR Clinical Trial

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

Healthy Japanese adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

YASOUKOUSO .Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Seishin-kai Medical Association Inc, Takara Medical Clinic

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2017

Year

07

Month

11

Day

URL releasing protocol

Publication of results

Published

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

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 related 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