HAMSV: Homeopathic Drug Proving Trial

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Completed

CT.gov ID

NCT01061229

Collaborator

Karl and Veronica Carstens Foundation (Other)

Enrollment

Location

Arms

Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: Homeopathic drug C12 Other: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Official Title:

Homeopathic Drug Proving Trial

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

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. [3 weeks]

Secondary Outcome Measures

Total number of proving symptoms [3 weeks]
Number of serious adverse events [3 weeks]
Qualitative differences in the profiles of characteristic proving symptoms [3 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Charité University	Berlin		Germany	10117

Sponsors and Collaborators

Charite University, Berlin, Germany
Karl and Veronica Carstens Foundation

Investigators

Principal Investigator: Claudia M Witt, Prof, MD, MBA, Charité University Berlin

Study Documents (Full-Text)

None provided.

More Information

Publications

Teut M, Hirschberg U, Luedtke R, Schnegg C, Dahler J, Albrecht H, Witt CM. Protocol for a phase 1 homeopathic drug proving trial. Trials. 2010 Jul 22;11:80. doi: 10.1186/1745-6215-11-80.

Responsible Party:

Claudia M. Witt, Prof. Dr. med., Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT01061229

Other Study ID Numbers:

ZS EK 15 - 287/09

First Posted:

Feb 3, 2010

Last Update Posted:

Jul 10, 2012

Last Verified:

Jul 1, 2012

Study Results

No Results Posted as of Jul 10, 2012