UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016429
Receipt number R000018526
Scientific Title Assessment of Safety of EQ-5-Containing Capsule in Case of Excess Ingestion
Date of disclosure of the study information 2015/02/09
Last modified on 2015/02/03 10:20:47

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Basic information

Public title

Assessment of Safety of EQ-5-Containing Capsule in Case of Excess Ingestion

Acronym

Safety of EQ-5-Containing Capsule

Scientific Title

Assessment of Safety of EQ-5-Containing Capsule in Case of Excess Ingestion

Scientific Title:Acronym

Safety of EQ-5-Containing Capsule

Region

Japan


Condition

Condition

Safty varification of a capsule containing EQ-5

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to evaluate safty of capsuls containing EQ-5 in case of excess ingestion by healty adults (Japanese males and females aged 20-70 years).

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Hematologic test
Blood biochemistry test
Urine analysis
Blood pressure/pulsation
Weight/body fat percentage/body mass index
Doctor's questions
Simplified menopausal index

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Oral ingestion of the test product (4 weeks)

Interventions/Control_2

Oral ingestion of the control product (4 weeks)

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

70 years-old >

Gender

Male and Female

Key inclusion criteria

1)Japanese males and females aged 20-70 years
2)Individuals who are healthy and do not treat any disease
3)Individuals who sign the consent document after explanation of this study
4)Individuals who are judged appropriate for the study by the principal investigator

Key exclusion criteria

1)Individuals using medical products
2)Individuals who have custom to ingest drugs or use topical application of drugs
3)Individuals who are currently or have treated with hormone therapy within the past 12 months
4)Individuals with serious anemia
5)Individuals whose bowel habit is irregular
6)Individuals who are sensitive to foods containing soybean, other foods, and medical products
7)Individuals who have a habit to ingest soymilk and soy isoflavone enriched foods in the past 1 month
8)Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments in the past 1 month or will ingest those foods during the test period
9)Individuals who have anamnesis or history of present illness of cardiovascular disease, nephritic disorder, hepatic inflammation, or pancreatitis
10)Individuals who have a comorbidity in digestive organs or a history of a comorbidity
11)Individuals whose observed data of AST (GOT) and ALT (GPT) is over 1.5 times of the standard value
12)Individuals whose observed data of UA is over 8.5mg/dL
13)Individuals whose observed data of indexes of lipid-based system is over 2.0 times of the standard value
14)Individuals whose observed data of HbA1c (NGSP) is over 7.0
15)Individuals whose observed data of systolic blood pressure is over 160mmHg or diastolic pressure is over 100mmHg
16)Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease
17)Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day)
18)Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months
19)Individuals whose average number of cigarettes for smoking is over 21/day
20)Individuals who participated in other clinical studies in the past three months
21)Individuals who are or are posslibly, or are lactating
22)Individuals judged inappropriate for the study by the principal

Target sample size

32


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masayuki Sano

Organization

Ginza Medicare Garden Clinic

Division name

Internal Department

Zip code


Address

7F 2-10-9 Ginza Chuo-ku Tokyo, 104-0061, JAPAN

TEL

03-3544-6881

Email

info@ginza-mgc.com


Public contact

Name of contact person

1st name
Middle name
Last name Toshiyasu Tamura

Organization

TES Holdings Co., Ltd

Division name

Department of Clinical Trial

Zip code


Address

6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, Japan

TEL

03-6801-8480

Homepage URL


Email

info@tes-h.co.jp


Sponsor or person

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Daicel Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2015 Year 02 Month 09 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 07 Month 22 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 02 Month 03 Day

Last modified on

2015 Year 02 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018526


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name