UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032966
Receipt No. R000037592
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
Date of disclosure of the study information 2018/06/14
Last modified on 2018/07/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 No longer recruiting
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 07 Month 23 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.