The Homeogenomic Trial

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02018341
• Other study ID #: 44817
• Status: Withdrawn
• Phase: N/A
• First received: June 20, 2013
• Last updated: December 20, 2013
• Start date: June 2013
• Est. completion date: February 2014

Study information

• Verified date: December 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Read and Speak English

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• homeopathic remedy in 30C potency

• Placebo

Locations

Country	Name	City	State
United States	Bastyr University	Kenmore	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characteristic symptoms	Symptoms that occur in participants that are characteristic of the homeopathic remedy being used in the study	6 days	No
Primary	gene expression	Changes in whole blood gene expression from just prior to beginning study medication until 48 hours after beginning study medication	2 days	No
Secondary	gene expression in sensitive provers	gene expression in participants receiving active study medication and who are classified as sensitive provers based on review of their symptoms will be compared to gene expression in placebo recipients.	2 days	No