The Homeogenomic Trial

December 20, 2013 updated by: James Taylor, University of Washington

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Kenmore, Washington, United States, 98028
        • Bastyr University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: homeopathic remedy in 30C potency
5 lactose globules containing a commonly used homeopathic remedy in the potency of 30C will be administered twice daily for 3 days
Other: homeopathic remedy in 30C potency
Placebo Comparator: placebo
5 lactose globules without any homeopathic remedy will be administered twice daily for 3 days
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characteristic symptoms
Time Frame: 6 days
Symptoms that occur in participants that are characteristic of the homeopathic remedy being used in the study
6 days
gene expression
Time Frame: 2 days
Changes in whole blood gene expression from just prior to beginning study medication until 48 hours after beginning study medication
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gene expression in sensitive provers
Time Frame: 2 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

June 20, 2013

First Submitted That Met QC Criteria

December 20, 2013

First Posted (Estimate)

December 23, 2013

Study Record Updates

Last Update Posted (Estimate)

December 23, 2013

Last Update Submitted That Met QC Criteria

December 20, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 44817

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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