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Completed

NCT Number: NCT01061229

Homeopathic Drug Proving Trial

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charité University

Berlin, State of Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

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.

    Time frame: 3 weeks

Secondary outcomes

  1. Total number of proving symptoms

    Time frame: 3 weeks

  2. Number of serious adverse events

    Time frame: 3 weeks

  3. Qualitative differences in the profiles of characteristic proving symptoms

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Karl and Veronica Carstens Foundation

Registry information

Acronym: HAMSV

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 3, 2010
Registry last updated
Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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