Protocol for a phase 1 homeopathic drug proving trial.

Trials
Michael TeutClaudia M Witt

Abstract

This study protocol adapts the traditional homeopathic drug proving methodology to a modern clinical trial design. Multi-centre, randomised, double-blind, placebo-controlled phase 1 trial with 30 healthy volunteers. The study consists of a seven day run-in period, a five day intervention period and a 16 day post-intervention observation period. Subjects, investigators and the statisticians are blinded from the allocation to the study arm and from the identity of the homeopathic drug. The intervention is a highly diluted homeopathic drug (potency C12 = 1024), Dose: 5 globules taken 5 times per day over a maximum period of 5 days. The placebo consists of an optically identical carrier substance (sucrose globules). Subjects document the symptoms they experience in a semi-structured online diary. The primary outcome parameter is the number of specific symptoms that characterise the intervention compared to the placebo after a period of three weeks. Secondary outcome parameters are qualitative differences in profiles of characteristic and proving symptoms and the total number of all proving symptoms. The number of symptoms will be quantitatively analysed on an intention-to-treat basis using ANCOVA with the subject's expectation and ...Continue Reading

Associated Clinical Trials

Feb 3, 2010·Claudia M. Witt

References

Nov 10, 2004·Homeopathy : the Journal of the Faculty of Homeopathy·H WalachG Rieberer
Dec 2, 2004·Forschende Komplementärmedizin und klassische Naturheilkunde = Research in complementary and natural classical medicine·H MöllingerH Walach
Jan 18, 2007·Homeopathy : the Journal of the Faculty of Homeopathy·F DantasL L M Weckx
Sep 13, 2008·Forschende Komplementärmedizin = Research in Complementary Medicine·Michael TeutUNKNOWN Wilsede Study Group for Homoeopathic Provings
May 8, 2009·Forschende Komplementärmedizin = Research in Complementary Medicine·Heribert MöllingerHarald Walach

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Citations

Jan 17, 2020·Complementary Medicine Research·Katharina GaertnerMartin Frei-Erb

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Clinical Trials Mentioned

NCT01061229

Software Mentioned

STAT
Atlas
SAS
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