A Randomized Double-blind Placebo Controlled Homeopathic Pathogenetic Trial (HPT) on Healthy Volunteers Proving XX in the Potency of 30C, "The Homeogenomic Trial"
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Characteristic symptoms
研究概览
简要总结
A randomized double-blind placebo controlled homeopathic pathogenetic trial (HPT) will be carried out on 30 healthy adult volunteers. The remedy used for the proving will be administered in a potency of 30C. The remedy being used is a common homeopathic remedy commercially available in the US, but the exact remedy is not disclosed to participants.The purpose of the proving is twofold: 1) to determine if there is a difference in symptoms between those receiving an active versus placebo medicine, and 2) to see if there is a difference in gene expression between those who receive the homeopathic remedy or placebo. It is hypothesized that participants receiving the active medication will have more symptoms characteristic of the remedy and have specific patterns of gene expression in whole blood that are different from those in placebo recipients. Participants will record symptoms in a diary for 3 days prior to administration of study medications, during 3 day of its administration and for 3 days following completion of the study medication. Blood will be drawn for gene expression studies on the day that the study medication is started and again after taking the study medication for approximately 48 hours. An additional, optional blood draw for possible future analysis of gene expression will be done at the end of the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Read and Speak English
排除标准
- •Acute illness in last 7 days
- •Chronic illness requiring daily medication
- •Use of homeopathic remedy within 4 weeks
- •Use of homeopathic remedy of 200C potency in past 2 months
- •Women who are pregnant or breastfeeding an infant
结局指标
主要结局
Characteristic symptoms
时间窗: 6 days
Symptoms that occur in participants that are characteristic of the homeopathic remedy being used in the study
gene expression
时间窗: 2 days
Changes in whole blood gene expression from just prior to beginning study medication until 48 hours after beginning study medication
次要结局
- gene expression in sensitive provers(2 days)
研究者
James Taylor
Professor
University of Washington
