Homeopathic Drug Proving Trial (HAMSV)

This study has been completed.
Sponsor:
Collaborator:
Karl and Veronice Carstens Foundation, Essen, Germany
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01061229
First received: February 2, 2010
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

The main aim of the study is to determine whether a homeopathic drug in the potency C12 provokes more characteristic homeopathic proving symptoms after three weeks compared to a placebo in healthy volunteers.

Secondary aims are to develop and to test a qualitative analysis methodology on which to base a definition for drug-specific (characteristic) symptoms and to compile a profile of characteristic homeopathic proving symptoms of the drug being trialled for therapeutic purposes.

This study protocol adapts the traditional homeopathic drug proving methodology to a modern clinical trial design.


Condition Intervention Phase
Healthy Subjects
Drug: Homeopathic drug C12
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Homeopathic Drug Proving Trial

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • The primary outcome parameter is the number of characteristic proving symptoms per subject, derived from the qualitative data analysis of the homeopathic proving drug compared to placebo. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total number of proving symptoms [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Number of serious adverse events [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • Qualitative differences in the profiles of characteristic proving symptoms [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: March 2010
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Homeopathic drug, potency C12 Drug: Homeopathic drug C12
Subjects in the intervention group are instructed to take five globules of the trial drug (potency C12), five times per day for a maximum of five days (5×5×5). The study medication is obtained from DHU (Germany), produced according to the Hahnemannian method. Subjects are asked to stop taking the medication, in agreement with their investigator, if they experience any of a predefined set of proving symptoms
Placebo Comparator: Placebo Other: Placebo
Placebo consists of pure sucrose globules (DHU, Germany) that are not potentiated nor impregnated with alcohol. The administration scheme is identical in the placebo control group to that of the intervention group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Medical doctors or medical students
  • Not being treated for any acute or chronic diseases on the day of inclusion
  • Written informed consent.

Exclusion Criteria:

  • Pregnant women or nursing mothers
  • Homeopathic treatment over the previous six weeks
  • Participation in another clinical trial during the last six months
  • Anyone with a personal or professional dependence on the study physician or sponsor
  • Anyone who has been placed in hospital or other institution by authorities or decree
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061229

Locations
Germany
Charité University
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Karl and Veronice Carstens Foundation, Essen, Germany
Investigators
Principal Investigator: Claudia M Witt, Prof, MD, MBA Charité University Berlin
  More Information

Additional Information:
Publications:
Responsible Party: Claudia M. Witt, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01061229     History of Changes
Other Study ID Numbers: ZS EK 15 - 287/09
Study First Received: February 2, 2010
Last Updated: July 9, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on April 15, 2014