- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00809263
Homeopathic Drug Provings
February 12, 2014 updated by: Integrative Medicine Institute
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.
Study Overview
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 Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tempe, Arizona, United States, 85282
- Southwest College of Naturopathic Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Symptoms associated with the administration of homeopathic remedy to health subjects.
Time Frame: 6 weeks per subject
|
6 weeks per subject
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Steven Messer, ND, Southwest College of Naturopathic Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Anticipated)
January 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
December 15, 2008
First Submitted That Met QC Criteria
December 16, 2008
First Posted (Estimate)
December 17, 2008
Study Record Updates
Last Update Posted (Estimate)
February 13, 2014
Last Update Submitted That Met QC Criteria
February 12, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HDPSCNM2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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