Protocol for efficacy of individualised homoeopathic medicine in cases of wrist ganglion: A prospective, parallel arm, randomised, double-blind, placebo-controlled trial

Abstract

Background and Objectives: Wrist ganglia are benign soft tissue tumours of controversial pathogenesis. Most of them are asymptomatic besides swelling but may be associated with pain, interference with activities and an increase in size. Non surgical management options are not much effective, and surgical excision may invite complications as well as longer recovery period. Homoeopathic treatment remains a very effective measure, but the documentation of it is not adequate. This protocol is designed to evaluate the effect of individualised homoeopathic medicines in cases of wrist ganglion. Materials and Methods: The study will be a prospective, parallel arm, randomised, double blind, placebo controlled trial. Participants (n = 154) will be allocated to individualised homoeopathic medicine group or placebo group by block randomisation. Enrolment will be done for 6 months, and every enrolled participant will be followed up for 8 months. Primary outcome measure will be changes in ganglion size at 8th month. Secondary outcome measures will be changes in pain visual analog scale score and patient rated wrist evaluation score at every month till 8th month. Discussion: The study may help in generating evidences which may be helpful to validate the effectiveness of individualised homoeopathic medicine in the wrist ganglion.