Standard Operating Procedure to Derive Homoeopathic Prophylaxis in COVID-19 through Prophylactic Clinical Trial—A Perspective

Abstract

AbstractThe pandemic coronavirus disease 2019 (COVID-19) has become a public health emergency of international concern affecting human health and economy across the world. The outbreak in India is accelerating even after enforcement of lockdown as well as promotion of hand hygiene, respiratory etiquettes and social distancing mainly due to nonavailability of specific antiviral medicine and vaccine. Historically, for the purpose of prevention and treatment, homoeopathy has shown its usefulness in recent and past epidemics using carefully selected medicines as genus epidemicus (GE) for each epidemic. In the present era of evidence-based medicine, usefulness of therapeutic agent as prophylaxis is recognised only after obtaining significant result in prophylactic clinical trial. Claims of usefulness of certain homoeopathic medicine as prophylaxis or GE of COVID-19 can be used to generate research hypothesis and can be tested through prophylactic clinical trial. In this article, outbreak investigation procedures are highlighted, necessity of epidemic preparedness with engagement of community is emphasised, several recent developments in clinical trial regulations for an outbreak are pointed out, among which online submission of research protocol, expedition of ethical review procedure, virtual meeting of the ethics committee, Good Participatory Practice Guidelines for Trials of Emerging (and re-emerging) Pathogens are mentioned. Standard operating procedures are discussed to conduct a comparative effectiveness research using cluster randomisation in a multidisciplinary approach to investigate the effectiveness of the homoeopathic medicine as a prophylaxis for COVID-19 which can be used by the policy makers as an effective public health intervention to stop transmission and prevent community spread of this highly infectious disease.