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Published on: September 20, 2019
Protocol for a phase 1 homeopathic drug proving trial.
Michael Teut1, Ute Hirschberg, Rainer Luedtke
1Institute for Social Medicine, Epidemiology and Health Economics, Charité University Medical Center, Berlin, Germany. michael.teut@charite.de
Trials
|July 24, 2010
Summary
This study adapted homeopathic drug proving for a clinical trial. The methodology is feasible for modern research, though regulatory classification needs adjustment.
Area of Science:
- Homeopathy research
- Clinical trial methodology
Background:
- Adapting traditional homeopathic drug proving to a modern clinical trial design.
- Study protocol registered under NCT01061229.
Purpose of the Study:
- To assess the feasibility of homeopathic drug proving within a modern clinical trial framework.
- To evaluate a highly diluted homeopathic drug (potency C12) against a placebo.
Main Methods:
- Multi-centre, randomized, double-blind, placebo-controlled phase 1 trial with 30 healthy volunteers.
- Five-day intervention with homeopathic C12 potency or placebo, followed by 16-day observation.
- Subjects used online diaries; symptoms analyzed quantitatively (ANCOVA) and qualitatively (Mayring's content analysis).
Main Results:
- The study demonstrated the feasibility of conducting homeopathic drug proving trials under Good Clinical Practice (GCP) guidelines.
- Quantitative and qualitative analyses were performed on collected symptom data.
Conclusions:
- Homeopathic drug proving trials can be conducted using clinical trial terminology and meet regulatory requirements.
- Current regulations classify these trials as phase 1, despite their aim to identify clinical indications rather than assess safety.
- Blinding of subjects and investigators is crucial to avoid bias, necessitating modifications to informed consent and study materials.
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