Homeopathic Drug Proving Trial

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Homeopathic drug C12; Other: Placebo

• Registration Number: NCT01061229
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-02
• Study First Submitted QC: 2010-02-02
• Study First Posted: 2010-02-03
• Study Start: 2010-03
• Primary Completion: 2010-07
• Study Completion: 2010-08
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-09
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Homeopathic drug, potency C12	Homeopathic drug C12	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Charité University; 🇩🇪 Berlin, Germany