Safty varification of a capsule containing EQ-5
Conditions
Interventions
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematologic test Blood biochemistry test Urine analysis Blood pressure/pulsation Weight/body fat percentage/body mass index Doctor's questions Simplified menopausal index | — |
Countries
Japan
Contacts
Public ContactToshiyasu Tamura
TES Holdings Co., Ltd Department of Clinical Trial
Outcome results
None listed