JPRN-UMIN000020484已完成未知
An open-label, uncontrolled exploratory study to investigate the efficacy assessment for function claims of Ripe Kumquats "Tama-Tama" - The clinical trial for efficacy assessment of Ripe Kumquats "Tama-Tama"
niversity of Miyazaki0 个研究点目标入组 12 人开始时间: 2016年1月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 12
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 70years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease, or who have history of those diseases. 2. Subjects who have a serious injury or surgical history within 12 weeks prior to this study. 3. Subjects who are less than one (10mm) by VAS scale relating to their fatigue. 4. Pre- or post-menopausal women having obvious changes in physical condition. 5. Subjects who are at risk of having allergic reaction to citrus foods including kumquat. 6. Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction. 7. Subjects who are heavy smoker (more than 21 cigarettes per day), or alcohol addicts (more than 20g per day alcohol), or alcohol or drug dependency or who have possibility of the dependency. 8. Subjects with irregular lifestyle, such as diet and sleep (shift workers, late-night workers, etc). 9. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study. 10. Subjects who donate either 400ml whole blood within 12 weeks or 200ml whole blood within four weeks or blood components within two weeks prior to this study. 11. Pregnant or lactating women or women expect to be pregnant during this study. 12. Subjects who have cognitive disorder or who have possibility of the disorder. 13. Subjects who participate and take the study drug in other clinical trials within 12 weeks prior to this study. 14. Subjects who are judged as unsuitable for this study by the principal investigator or subinvestigators.
研究者
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