Homeopathic Drug Provings

NCT ID: NCT00809263

Last Updated: 2014-02-13

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WITHDRAWN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

2009-10-31

Study Completion Date

2012-12-31

Brief Summary

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In a homeopathic drug proving a homeopathically prepared substance is administered to healthy volunteers in order to produce the symptoms specific to that substance and thereby reveal its inherent curative powers. During a homeopathic drug proving the goal is to provoke temporary symptoms (or "artificial illness") associated with the homeopathic medication. These symptoms are then arranged to form a symptom pattern or 'remedy picture' which is specific to that particular homeopathic substance and provides the basis for a better understanding of the possible effects of that homeopathic remedy in patients.

Detailed Description

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The duration of these homeopathic drug provings are six week per subject (42 days). The central investigational tool of the homeopathic drug proving is the journal kept by each subject from DAY 1-35. The subject describes the symptoms they experience in their own words in the journal daily. During the 7 day run-in phase, the subject notes in their journal their current state of health, the daily rhythm of their life, and any other signs or symptoms that occur on a daily basis. This will also enhance familiarity with self-observation and the recording of signs and symptoms. After completion of this run-in phase an evaluation including journal check will occur on DAY 7. During the following 4 weeks (observation periods DAY 8-14, 22-28; wash-out period DAY 15-21 and 29 - 35) the subject documents all signs or symptoms that occur in his/her journal on a daily basis. During this period, subject interviews will take place on DAY 15, DAY 21. DAY 29 and DAY 36. During the 7 day follow up (post observation period, DAY 36-42) the subject will be contacted to check if any additional symptoms and/or adverse events occurred.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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homeopathic remedy

Homeopathic remedy 12C potency, 10 drops TID X 7 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years and \< 75 years
* General state of good health
* Continuation of the usual habits and patterns of daily living
* Written informed consent obtained and willingness to comply with the requirements of the study

Exclusion Criteria

* Any major life changes e.g. moving, getting married or divorced etc.
* Current or expected medical treatment or surgery during this homeopathic drug proving
* Surgery within the past four weeks prior to enrollment into the homeopathic drug proving
* Use of homeopathic medicines \> 30 C or contraceptive pills in the month prior to enrollment into the homeopathic drug proving
* Alcohol or drug abuse
* Pregnancy or nursing (or anticipating pregnancy during this homeopathic drug proving)
* Incompetence, or inability of understanding the nature, meaning and consequences of the homeopathic drug proving or inadequate completion of the journal form DAY 1-7.
* Participation in another clinical trial at the same time or within the last 4 weeks.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Southwest College of Naturopathic Medicine

OTHER

Sponsor Role collaborator

Heel GmbH

UNKNOWN

Sponsor Role collaborator

Integrative Medicine Institute

OTHER

Sponsor Role lead

Responsible Party

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Southwest College of Naturopathic Medicine

Principal Investigators

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Steven Messer, ND

Role: PRINCIPAL_INVESTIGATOR

Southwest College of Naturopathic Medicine

Locations

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Southwest College of Naturopathic Medicine

Tempe, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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HDPSCNM2008

Identifier Type: -

Identifier Source: org_study_id

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