Safety evaluation of an excessive consumption of a botanical extract-formulated food - Placebo control double blind parallel group comparison clinical trial - - Safety evaluation of an excessive consumption of a botanical extract-formulated food

Maruzen Pharmaceuticals Co., Ltd.0 个研究点目标入组 52 人开始时间: 2018年1月5日最近更新: 2023年10月17日

适应症

试验速览

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•1. Subjects who systolic blood pressure is less than 90 mmHg. 2. Subjects who equal to or more than 30kg/m2of BMI. 3. Subjects who fall under diagnostic criteria of metabolic syndrome 4. Subjects who given surgery, or taken medication due to serious illness within a month 5. Subject who present heart, liver, kidney disorders. 6. Subjects who are taking drugs, foods for specified health use or functional foods which could affect this study. 7. Subjects who Females in pregnancy, lactation and scheduled pregnancy period. 8. Subjects who with heavy use of alcohol, and heavy smoking. 9. Subject who have been felt ill by blood collection. 10. Subjects who donated 200 ml or more of blood within a month prior to the study 11.Subjects who with irregular eating habits.(Night shift worker) 12. Subjects who plan business trip or trip for 10 consecutive days or more. 13. Subjects who have allergy related to the study foods 14. Subjects who have chronic diarrhea or chronic coprostasis 15. Subjects already participating in other clinical trials, or planning to participate during this examination period 16. Subjects who can not agree with preliminary explanation 17. Subjects who are deemed to be unsuitable by the investigator.

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