UMIN-CTR Clinical Trial

Public title

A verification study of safety evaluation of excessive consumption of the test food containing 95% LB-Scr (Sparassis crispa powder) in healthy subjects: an open-label trial

Acronym

A verification study of safety evaluation of excessive the test food consumption in humans

Scientific Title

A verification study of safety evaluation of excessive consumption of the test food containing 95% LB-Scr (Sparassis crispa powder) in healthy subjects: an open-label trial

Scientific Title:Acronym

A verification study of safety evaluation of excessive the test food consumption in humans

Region

Japan

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To identify the safety of overdose the test food for 4 weeks in healthy Japanese subjects

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. Physical examination
2. Urinalysis
3. Blood test
4. Subjective symptoms (the Likert scale)

* Assess these at screening (before consumption) and at 2 and 4 weeks after consumption

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Duration: 4 weeks
Test material: Tablets containing 95% LB-Scr (Sparassis crispa powder)
Dose: Take 20 tablets per day
Administration: Take a total of 20 tablets with water or warm water per day over the course of 3 separate servings: before breakfast, lunch, and dinner

* Daily dose should be taken within the day.

Interventions/Control_2

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Healthy Japanese adult subjects

2. Subjects who are judged as eligible to participate in the study by the physician

Key exclusion criteria

1. A medical history of malignant tumor, heart failure or myocardial infarction

2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily

4. Subjects who are currently taking medications (including herbal medicines) and supplement

5. Subjects who are allergic to medicines and/or the test food related products

6. Subjects who are pregnant, breast-feeding, or planning to become pregnant

7. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial

8. Subjects who are judged as ineligible to participate in the study by the physician

Target sample size

15

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, Japan.

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, Japan.

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

INTERTRADE Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara 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)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Date of disclosure of the study information

2018

Year

06

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Recruitment status

Completed

Date of protocol fixation

2018

Year

06

Month

11

Day

Date of IRB

Anticipated trial start date

2018

Year

06

Month

15

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

06

Month

13

Day

Last modified on

2018

Year

10

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037592