UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The verification study for improving the blood flow: A randomized double-blind placebo-controlled trial
Title of the study (Brief title)	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	Kazuo YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
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	Naoko SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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
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