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Homeopathic Drug Provings

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ClinicalTrials.gov Identifier: NCT00809263
Recruitment Status : Withdrawn
First Posted : December 17, 2008
Last Update Posted : February 13, 2014
Sponsor:
Collaborators:
Southwest College of Naturopathic Medicine
Heel GmbH
Information provided by:
Integrative Medicine Institute

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: homeopathic remedy Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Randomized, Double-blind, Placebo-controlled, Homeopathic Drug Proving Using a Crossover Design
Study Start Date : October 2009
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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Intervention Details:
  • Drug: homeopathic remedy
    Homeopathic remedy 12C potency, 10 drops TID X 7 days

Outcome Measures
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Primary Outcome Measures :
  1. Symptoms associated with the administration of homeopathic remedy to health subjects. [ Time Frame: 6 weeks per subject ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00809263


Locations
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United States, Arizona
Southwest College of Naturopathic Medicine
Tempe, Arizona, United States, 85282
Sponsors and Collaborators
Integrative Medicine Institute
Southwest College of Naturopathic Medicine
Heel GmbH
Investigators
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Principal Investigator: Steven Messer, ND Southwest College of Naturopathic Medicine
More Information
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Responsible Party: Steven Messer ND DHANP, Southwest College of Naturopathic Medicine
ClinicalTrials.gov Identifier: NCT00809263    
Other Study ID Numbers: HDPSCNM2008
First Posted: December 17, 2008    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014
Keywords provided by Integrative Medicine Institute:
homeopathy
homeopathic drug proving
Document symptoms associated with administration of a homeopathic remedy.