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The Homeogenomic Trial

NCT ID: NCT02018341

Last Updated: 2013-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-02-28

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.

Detailed Description

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Conditions

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Healthy

Keywords

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Assessment of biologic activity of a homeopathic remedy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

homeopathic remedy in 30C potency

Intervention Type OTHER

placebo

5 lactose globules without any homeopathic remedy will be administered twice daily for 3 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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homeopathic remedy in 30C potency

Intervention Type OTHER

Placebo

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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James Taylor

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James A Taylor, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Bastyr University

Kenmore, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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44817

Identifier Type: -

Identifier Source: org_study_id