A Randomized, Double-blind, Placebo-controlled, Homeopathic Drug Proving Using a Crossover Design
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Symptoms associated with the administration of homeopathic remedy to health subjects.
研究概览
简要总结
In a homeopathic drug proving a homeopathically prepared substance is administered to healthy volunteers in order to produce the symptoms specific to that substance and thereby reveal its inherent curative powers. During a homeopathic drug proving the goal is to provoke temporary symptoms (or "artificial illness") associated with the homeopathic medication. These symptoms are then arranged to form a symptom pattern or 'remedy picture' which is specific to that particular homeopathic substance and provides the basis for a better understanding of the possible effects of that homeopathic remedy in patients.
详细描述
The duration of these homeopathic drug provings are six week per subject (42 days). The central investigational tool of the homeopathic drug proving is the journal kept by each subject from DAY 1-35. The subject describes the symptoms they experience in their own words in the journal daily. During the 7 day run-in phase, the subject notes in their journal their current state of health, the daily rhythm of their life, and any other signs or symptoms that occur on a daily basis. This will also enhance familiarity with self-observation and the recording of signs and symptoms. After completion of this run-in phase an evaluation including journal check will occur on DAY 7. During the following 4 weeks (observation periods DAY 8-14, 22-28; wash-out period DAY 15-21 and 29 - 35) the subject documents all signs or symptoms that occur in his/her journal on a daily basis. During this period, subject interviews will take place on DAY 15, DAY 21. DAY 29 and DAY 36. During the 7 day follow up (post observation period, DAY 36-42) the subject will be contacted to check if any additional symptoms and/or adverse events occurred.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years and < 75 years
- •General state of good health
- •Continuation of the usual habits and patterns of daily living
- •Written informed consent obtained and willingness to comply with the requirements of the study
排除标准
- •Any major life changes e.g. moving, getting married or divorced etc.
- •Current or expected medical treatment or surgery during this homeopathic drug proving
- •Surgery within the past four weeks prior to enrollment into the homeopathic drug proving
- •Use of homeopathic medicines > 30 C or contraceptive pills in the month prior to enrollment into the homeopathic drug proving
- •Alcohol or drug abuse
- •Pregnancy or nursing (or anticipating pregnancy during this homeopathic drug proving)
- •Incompetence, or inability of understanding the nature, meaning and consequences of the homeopathic drug proving or inadequate completion of the journal form DAY 1-
- •Participation in another clinical trial at the same time or within the last 4 weeks.
结局指标
主要结局
Symptoms associated with the administration of homeopathic remedy to health subjects.
时间窗: 6 weeks per subject
次要结局
未报告次要终点