Homeopathic Drug Provings
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 3/1/2014 |
| Start Date: | January 2009 |
| End Date: | December 2012 |
| Contact: | Steven Messer, ND |
| Email: | s.messer@scnm.edu |
| Phone: | 4802229240 |
A Randomized, Double-Blind, Placebo-Controlled, Homeopathic Drug Proving Using a Crossover Design
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.
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.
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.
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.
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.
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