Homeopathic Drug Provings

Healthy Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Homeopathic Drug Proving Using a Crossover Design

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00809263
• Other study ID #: HDPSCNM2008
• Status: Withdrawn
• Phase: N/A
• First received: December 15, 2008
• Last updated: February 12, 2014
• Start date: October 2009
• Est. completion date: December 2012

Study information

• Verified date: February 2014
• Source: Integrative Medicine Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• homeopathic remedy
Homeopathic remedy 12C potency, 10 drops TID X 7 days

Locations

Country	Name	City	State
United States	Southwest College of Naturopathic Medicine	Tempe	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Integrative Medicine Institute	Heel GmbH, Southwest College of Naturopathic Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms associated with the administration of homeopathic remedy to health subjects.		6 weeks per subject	No