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

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 25kg/m of BMI 3. Subjects who given surgery, or taken medication due to serious illness within a month 4. Subject who present heart, liver, kidney disorders 5. Subjects who are taking drugs, foods for specified health use or functional foods which could affect this study 6. Subjects who Females in pregnancy, lactation and scheduled pregnancy period 7 Subjects who with heavy use of alcohol, and heavy smoking 8. Subject who have been felt ill by blood collection 9. Subjects who donated 200 ml or more of blood within a month prior to the study 10 Subjects who with irregular eating habits(Night shift worker) 11. Subjects who plan business trip or trip for 10 consecutive days or more 12. Subjects who have allergy related to the test foods 13. Subjects who have chronic diarrhea or chronic coprostasis 14.Subjects who already participating in other clinical trials, or planning to participate during this examination period 15. Subjects who can not agree with prliminary explanation 16. Subjects who are deemed to be unsuitable by the investigator

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