UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	A verification study of safety evaluation of excessive the test food consumption in humans
Region	Japan

Condition
Condition	Healthy Japanese subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

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, Japan.
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, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	INTERTRADE Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara 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) Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 06 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 06 Month 13 Day
Last modified on	2018 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037592