Homoeopathic Drug Proving: Randomised double-blind placebo-controlled trial

Abstract

Background: The methodology of Drug Proving has evolved considerably since the times of Dr. Hahnemann. Standardisation of a proving process and quality of proving studies has been a major consideration for research over the years. Proving guidelines have been developed by various international bodies such as Homoeopathic Pharmacopoeia Committee of United States (HPCUS), European Commission of Homoeopathy (ECH) and Liga Medicorum Homoeopathica Internationalis (LMHI). Drug proving has been a major research activity of the Central Council for Research in Homoeopathy (CCRH). CCRH had over the years devised its own methodology for drug proving. A protocol for the drug proving program of the Council has been developed by harmonising the CCRH methodology with that detailed in internationally developed guidelines. Methodology: This is a generic protocol, which will be applicable for drugs being proved by the Council. These will be multi-centric, prospective, parallel arm, randomised, double-blind, placebo-controlled studies. It is recommended to have at least 30 provers who can complete the total duration of proving. The Investigational Proving Substance (IPS) will be proved in two potencies. Inter- Prover and Intra- Prover placebo control will be maintained. Proving symptoms generated will be analysed on pre-defined criteria, and characteristic symptoms of the IPS will be identified. Discussion: The protocol aims at combining the possible methods to increase the quality and to minimize bias in the study, at the same time ensuring that the IPS is proved sufficiently to evolve a pathogenesis which can then further be subjected for appropriate clinical response in patients. The protocol is open for discussion and readers are invited to send their comments and reviews on the protocol.