Homeopathic Drug Proving Trial (HAMSV)

July 9, 2012 updated by: Claudia M. Witt, Charite University, Berlin, Germany

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 1

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

  • Germany
      • Berlin, Germany, 10117
        • Charite University

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Total number of proving symptoms
Time Frame: 3 weeks
3 weeks
Number of serious adverse events
Time Frame: 3 weeks
3 weeks
Qualitative differences in the profiles of characteristic proving symptoms
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Karl and Veronica Carstens Foundation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

February 2, 2010

First Submitted That Met QC Criteria

February 2, 2010

First Posted (Estimate)

February 3, 2010

Study Record Updates

Last Update Posted (Estimate)

July 10, 2012

Last Update Submitted That Met QC Criteria

July 9, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • ZS EK 15 - 287/09

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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