Individualized homeopathic medicines in chronic rhinosinusitis: Randomized,double-blind, placebo-controlled, feasibility trial

Chronic rhinosinusitis (CRS) is one of the most common chronic and debilitating conditions affecting 10-15% of the world population. An estimated 134 million Indians suffer from CRS. It has been shown to impair quality of life (QoL) and increase the risk of depression, anxiety, mood and sleep disorders and has significant morbidity and healthcare expenditure. Current management techniques mainly target to reduce inflammation with a variable results and endoscopic sinus surgery (ESS). Though homeopathy is one of the popular choice of CRS patients but effects of classical or individualized form of homeopathy (IH) remained unexplored through RCTs. In this double-blind, randomized, placebo-controlled trial at D. N. De Homoeopathic Medical College and Hospital, 40 patients suffering from CRS will be randomized to receive either individualized homoeopathic medicines (verum; n=20) or identical-looking placebo (control; n=20). We aim to address the feasibility issues of conducting a definitive efficacy trial of individualized homeopathy (IH) in treatment of CRS and to investigate whether there are any differences in outcomes between these two groups over 2 months of intervention. Sino-nasal Outcome Test-22 (SNOT-22) and EQ-5D-5L will be used as the primary and secondary outcome measures respectively. Feasibility issues will be checked and comparative analysis will be carried out to examine group differences, if any. Results will be published in scientific journals.