JPRN-UMIN000043073已完成未知
A clinical study to evaluate the safety of plant-extracts containing foods. -- Randomized, Placebo controlled, Double-Blind Parallel Study -- (SME-2020-01-HRCT) - A clinical study to evaluate the safety of plant-extracts containing foods.
SUNTORY MONOZUKURI EXPERT LIMITED0 个研究点目标入组 48 人开始时间: 2021年2月4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
- 48
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) Those who have difficulty in swallowing (2) Those who are receiving any treatment at the screening (3) Those with systolic blood pressure less than 90 mmHg at the start of ingestion (4) Women who are/might be pregnant or lactating during the study (5) Those who have taken >=200 mL whole blood or blood donation within 4 weeks before the start of the intake (6) Men who have taken =>400 mL whole blood within 12 weeks before the start of intake (7) Women who have taken =>400 mL whole blood within 16 weeks before the start of intake (8) Men who have taken =>1,200 mL whole blood total (including the sampling of this study) within 12 months before the start of intake (9) Women who have taken =>800 mL whole blood total (including the sampling of this study) within 12 months before the start of intake (10) Those who are participating in other study or planning to participate or participated within the past 4 weeks. (11) Those who are: a) heart, liver, or kidney disease (including complications of other diseases) b) having a history of cardiovascular disease c) diabetes d) allergic to test foods e) undergoing treatment for or have a history of serious illnesses such as cancer and tuberculosis f) positive or suspected to be positive in the infectious disease test (12) Those who regularly use pharmaceuticals (including quasi-drugs), foods for specified health use, foods with functional claims or health foods. (13) Those who smoke an average of 21 or more cigarettes in a day (14) Those who drink an average of more than 60 g of pure alcohol in a day (15) Those who have an extremely irregular eating habit (16) Shift workers or late night workers (17) Others who are judged inappropriate for participant by the investigator
研究者
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