JPRN-UMIN000048998已完成Unknown
Safety evaluation of a single intake of a test food containing Plant extract- an open-label, single arm study - Safety evaluation of a single intake of a test food containing Plant extract
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 65years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Subjects with a serious medical history and those suffering from hepatic disorder, renal or cardiac disease, organ failure, diabetes mellitus, or other serious diseases 2. Subjects with a history of gastrointestinal resection (except for appendicectomy) 3. Subjects with chronic diseases under treatment 4. Subjects who are at risk of developing an allergy in relation to the study 5. Subjects who are aware that the frequency of defecation or stool characteristics may easily change significantly as gastrointestinal symptoms. 6. Heavy drinkers of alcohol (>60 g/day of pure alcohol) or excessive smokers (>20 cigarettes/day) or smokers who cannot quit smoking during the study under unified control. 7. Pregnant or planning to become pregnant or breastfeeding during the study period 8. Subjects who work late at night, work overtime for a long period of time, or work the irregular shifts 9. Subjects who are participating in other study in which test foods or drugs are taken, or in which cosmetics or drugs are applied, or who plan to participate in other study during the study period. 10. Subjects who may need to avoid consuming the food or beverage used in the study with religious or other reasons, since the origin of the ingredients are not specified. 11. Those who are judged to be unsuitable as subjects based on the results of the background survey. 12. Subjects whose physical or clinical examination data prior to the start of intake are significantly out of the reference range. 13. Subjects who are judged to be inappropriate to participate in this study by the investigator.
研究者
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