Homeopathic Drug Proving Trial

NCT01061229 | Completed Phase 1 DMC

• 1 other identifier: ZS EK 15 - 287/09
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Homeopathic drug, potency C12

EXPERIMENTAL

Drug: Homeopathic drug C12

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Homeopathic drug C12 DRUG

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

Homeopathic drug, potency C12

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical doctors or medical students
• Written informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Karl and Veronica Carstens Foundation: collaborator

Study Sites (1)

Charité University

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (2)

• 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.

  PMID: 20649979 BACKGROUND

• Teut M, Dahler J, Hirschberg U, Luedtke R, Albrecht H, Witt CM. Homeopathic drug proving of Okoubaka aubrevillei: a randomised placebo-controlled trial. Trials. 2013 Apr 5;14:96. doi: 10.1186/1745-6215-14-96.

  PMID: 23561008 DERIVED

Study Officials

• Claudia M Witt, Prof, MD, MBA

  Charité University Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 3, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

DE (1)