CTRI/2017/12/010788已完成1 期
Phase 1 clinical trial for assessment of safety of a multi component botanical therapeutic (SKBDEVI) in healthy human volunteers
SK Biolabs1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 1999年1月2日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Any toxic side effects after oral intake of SKBDEVI such as fever, nausea, vomiting, headache, depression, irritation, anxiety, palpitation, choking, fainting, cough, skin rashes etc.
研究概览
简要总结
Multi component botanical therapeutic SKBDEVI causes no toxicity in healthy human volunteers except some volunteers reported mild constipation after 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy Human Volunteers.
排除标准
- •Patients suffering from any disease.
结局指标
主要结局
Any toxic side effects after oral intake of SKBDEVI such as fever, nausea, vomiting, headache, depression, irritation, anxiety, palpitation, choking, fainting, cough, skin rashes etc.
时间窗: 1 day
次要结局
- Any toxic side effects after oral intake of SKBDEVI such as fever, nausea, vomiting, headache, depression, irritation, anxiety, palpitation, choking, fainting, cough, skin rashes etc.(4 weeks)
研究者
研究点 (1)
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