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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016429
Receipt No. 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

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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
Institute TES Holdings Co., Ltd.
Institute
Department

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
URL(English) https://upload.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


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