Unique ID issued by UMIN | UMIN000016429 |
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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 |
Assessment of Safety of EQ-5-Containing Capsule in Case of Excess Ingestion
Safety of EQ-5-Containing Capsule
Assessment of Safety of EQ-5-Containing Capsule in Case of Excess Ingestion
Safety of EQ-5-Containing Capsule
Japan |
Safty varification of a capsule containing EQ-5
Not applicable | Adult |
Others
NO
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).
Safety
Not applicable
Hematologic test
Blood biochemistry test
Urine analysis
Blood pressure/pulsation
Weight/body fat percentage/body mass index
Doctor's questions
Simplified menopausal index
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
2
Treatment
Other |
Oral ingestion of the test product (4 weeks)
Oral ingestion of the control product (4 weeks)
20 | years-old | <= |
70 | years-old | > |
Male and Female
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
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
32
1st name | |
Middle name | |
Last name | Masayuki Sano |
Ginza Medicare Garden Clinic
Internal Department
7F 2-10-9 Ginza Chuo-ku Tokyo, 104-0061, JAPAN
03-3544-6881
info@ginza-mgc.com
1st name | |
Middle name | |
Last name | Toshiyasu Tamura |
TES Holdings Co., Ltd
Department of Clinical Trial
6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, Japan
03-6801-8480
info@tes-h.co.jp
TES Holdings Co., Ltd.
Daicel Corporation
Profit organization
NO
2015 | Year | 02 | Month | 09 | Day |
Unpublished
Completed
2014 | Year | 07 | Month | 01 | Day |
2014 | Year | 07 | Month | 22 | Day |
2015 | Year | 02 | Month | 03 | Day |
2015 | Year | 02 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018526
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