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Homeopathic Drug Provings

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborators:
Southwest College of Naturopathic Medicine
Heel GmbH
Information provided by:
Integrative Medicine Institute
ClinicalTrials.gov Identifier:
NCT00809263
First received: December 15, 2008
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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 Intervention
Healthy
Drug: homeopathic remedy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Randomized, Double-blind, Placebo-controlled, Homeopathic Drug Proving Using a Crossover Design

Further study details as provided by Integrative Medicine Institute:

Primary Outcome Measures:
  • Symptoms associated with the administration of homeopathic remedy to health subjects. [ Time Frame: 6 weeks per subject ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: homeopathic remedy
    Homeopathic remedy 12C potency, 10 drops TID X 7 days
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809263

Locations
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
Principal Investigator: Steven Messer, ND Southwest College of Naturopathic Medicine
  More Information

No publications provided

Responsible Party: Steven Messer ND DHANP, Southwest College of Naturopathic Medicine
ClinicalTrials.gov Identifier: NCT00809263     History of Changes
Other Study ID Numbers: HDPSCNM2008
Study First Received: December 15, 2008
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Integrative Medicine Institute:
homeopathy
homeopathic drug proving
Document symptoms associated with administration of a homeopathic remedy.

ClinicalTrials.gov processed this record on November 25, 2014