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临床试验/NCT02018341
NCT02018341撤回不适用

A Randomized Double-blind Placebo Controlled Homeopathic Pathogenetic Trial (HPT) on Healthy Volunteers Proving XX in the Potency of 30C, "The Homeogenomic Trial"

University of Washington2 个研究点 分布在 1 个国家开始时间: 2013年6月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Taylor

Professor

University of Washington

研究点 (2)

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