The Homeogenomic Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Other: homeopathic remedy in 30C potency
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: homeopathic remedy in 30C potency<br>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<br> <br> |
| Placebo Comparator: placebo<br>5 lactose globules without any homeopathic remedy will be administered twice daily for 3 days | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristic symptoms | Symptoms that occur in participants that are characteristic of the homeopathic remedy being used in the study | 6 days | 
| gene expression | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Assessment of biologic activity of a homeopathic remedy