Protocol for a phase 1 homeopathic drug proving trial.

ABSTRACT:

Background

This study protocol adapts the traditional homeopathic drug proving methodology to a modern clinical trial design.

Method

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 experienc

SUBMITTER: Teut M 

PROVIDER: S-EPMC2917434 | biostudies-literature | 2010 Jul

REPOSITORIES: biostudies-literature