Homeopathic Drug Proving Trial

Healthy Subjects Clinical Trial

— HAMSV  

Official title:

Homeopathic Drug Proving Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061229
• Other study ID #: ZS EK 15 - 287/09
• Status: Completed
• Phase: Phase 1
• First received: February 2, 2010
• Last updated: July 9, 2012
• Start date: March 2010
• Est. completion date: August 2010

Study information

• Verified date: July 2012
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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

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.

Locations

Country	Name	City	State
Germany	Charité University	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Karl and Veronica Carstens Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Total number of proving symptoms		3 weeks	No
Secondary	Number of serious adverse events		3 weeks	Yes
Secondary	Qualitative differences in the profiles of characteristic proving symptoms		3 weeks	No