Clinical study to evaluate the efficacy of Mentosoothe Compound in the management of Attention Deficit / Hyperactivity Disorder

Abstract

Introduction: DSM-5 defines Attention-Deficit/Hyperactivity Disorder as having a persistent pattern of hyperactivity or inattention. This affects social, emotional, cognitive, and academic performance, behavioural skills in children and adolescents. The suffering child should have more than 6 symptoms of a particular type. Due to aetiology of Dhee Dhriti and Smriti, which results in imbalance of Kala and Karma and leads to incorrect interaction of the senses with their aims (Asatmyendriyartha Samyoga), gives rise to inattention, hyperactivity and impulsivity. Considering the nature of symptomatologic manifestation, it can be correlated with Unmada, more specifically Vata-Pittaja Unmada. Ayurveda addresses ADHD with both internal medicines and external therapies. Mentosoothe compound is such a polyherbal compound it contains Medhya, Balya, Deepana and Rasayana drugs in extract form. Aim of the present study to evaluate the efficacy of mentosoothe compound in the management of Attention-Deficit/Hyperactivity Disorder. Objective of the study is to promote cognitive performance with improvement in the quality of life by providing an effective and safe treatment option. Materials and Methods: The present study will be conducted as a randomized clinical study including minimum 40 patients, divided into two groups. Mentosoothe compound A and Mentosoothe compound B will be given to groups with fixed dosages. Assessment will be done on every 15th day during 2 months of clinical trial and final follow up will be done one month after completion of clinical trial. Result: The results will give the data on comparative effectiveness of the Mentosoothe compounds on ADHD. Discussion and Conclusion: The outcome of this trial will render a way forward to effective management of ADHD in children.