TCTR20201020001已完成1 期
Phase I clinical trial to evaluate safety, pharmacokinetics and immunomodulatory activity of the capsule formulation of the standardized extract of Atractylodes lancea
ational Research Council of Thailand0 个研究点目标入组 48 人开始时间: 2020年10月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 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
- 20 Years 至 40 Years（—）
- 性别
- All
入选标准
- •non-smokers and non-alcohol drinkers and were residents of Bangkok or suburb areas were recruited into the study. Additional inclusion criteria were (i) absence of acute or chronic diseases that could affect vital organ functions, (ii) no history of surgery within the past six months, (ii) no history of hypersensitivity reactions or idiosyncratic reactions to drugs or herbal products, (iv) no concurrent or history of administration of drugs or herbal products within the past two weeks (except antipyretic or anti-emetic drugs), (v) no history or current drug abuse, (vi) ability to communicate (reading, writing, and speaking) effectively, and (vii) willing to give informed consent for study participation.
排除标准
- •with (i) clinical significant abnormality of physical examination, (ii) clinical significant abnormality of electrocardiograms (ECG) or chest x-ray, (iii) pregnancy or lactation, (iv) blood tests positive for HBsAg, HCV, or HIV, (v) abnormality in blood coagulation or history or concurrent use of anticoagulants or antiplatelets, or (vi) participation in any other study in the past three months.
研究者
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