Efficacy of Individualized Homoeopathic Medicines in the Management of Paediatric Enuresis: A Double-blind, Randomized, Placebo-controlled Trial

Enuresis is a very common problem in childhood. When it persists beyond early childhood, it can be very stressful and distressing to the affected child as well as the family members. It results in severe psychosocial impact and also hampers the normal academic and recreational activities of children. Achieving continence as well as improving quality of life is therefore the main goal of treatment and that will lead to improvement of self-worth and self-confidence. Paediatric enuresis reveals an overall global prevalence ranging from 4 to 16% and prevalence in India is 7.61%–16.3%. Though the use of homoeopathic medicines is prevalent globally to treat the condition, rigorous research evidences in support of homoeopathy in paediatric enuresis has remained compromised. Under such circumstances, we intend to undertake this research project to evaluate the efficacy and safety of homoeopathic medicines in the treatment of enuresis in children. A double-blind Randomized(2:1) placebo-controlled trial will be conducted on 159 paediatric participants with complaints of enuresis. The aim of the trial is to find out the efficacy of IHM in the management of Paediatric enuresis over four months of intervention. The objectives are to detect the group differences in DVISS (Dysfunctional Voiding and Incontinence Scoring System) score (DVISS; primary objective), PEMQOL score, and MYMOP-2 score (secondary objective) between IHM and placebo in the management of paediatric enuresis every month over 4 months of intervention. ITT & PP analysis will be done to detect group differences using tests of unequal variance  (e.g., Welch’s t-test) and ANOVA model respectively. The results will be published in scientific journals.