The Homeogenomic Trial

Not Applicable

Withdrawn

• Conditions: Healthy
• Interventions: Other: homeopathic remedy in 30C potency; Other: Placebo

• Registration Number: NCT02018341
• Lead Sponsor: University of Washington

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-20
• Primary Completion: 2013-10
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-20
• Last Update Submitted: 2013-12-20
• Study First Posted: 2013-12-23
• Last Update Posted: 2013-12-23
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
homeopathic remedy in 30C potency	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
placebo	Placebo	5 lactose globules without any homeopathic remedy will be administered twice daily for 3 days

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
gene expression in sensitive provers	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.

Trial Locations

Locations (1)

Bastyr University; 🇺🇸 Kenmore, Washington, United States