Homeopathic Drug Proving Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- The primary outcome parameter is the number of characteristic proving symptoms per subject, derived from the qualitative data analysis of the homeopathic proving drug compared to placebo.
研究概览
简要总结
The main aim of the study is to determine whether a homeopathic drug in the potency C12 provokes more characteristic homeopathic proving symptoms after three weeks compared to a placebo in healthy volunteers.
Secondary aims are to develop and to test a qualitative analysis methodology on which to base a definition for drug-specific (characteristic) symptoms and to compile a profile of characteristic homeopathic proving symptoms of the drug being trialled for therapeutic purposes.
This study protocol adapts the traditional homeopathic drug proving methodology to a modern clinical trial design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medical doctors or medical students
- •Not being treated for any acute or chronic diseases on the day of inclusion
- •Written informed consent.
排除标准
- •Pregnant women or nursing mothers
- •Homeopathic treatment over the previous six weeks
- •Participation in another clinical trial during the last six months
- •Anyone with a personal or professional dependence on the study physician or sponsor
- •Anyone who has been placed in hospital or other institution by authorities or decree
研究组 & 干预措施
Homeopathic drug, potency C12
干预措施: Homeopathic drug C12 (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
The primary outcome parameter is the number of characteristic proving symptoms per subject, derived from the qualitative data analysis of the homeopathic proving drug compared to placebo.
时间窗: 3 weeks
次要结局
- Total number of proving symptoms(3 weeks)
- Number of serious adverse events(3 weeks)
- Qualitative differences in the profiles of characteristic proving symptoms(3 weeks)
研究者
Claudia M. Witt
Prof. Dr. med.
Charite University, Berlin, Germany