A Protocol for a Systematic Review to Study the Efficacy and Safety of Ayurveda Intervention in Children and Adolescent with Attention-deficit/Hyperactivity Disorder

Abstract

Background: Various clinical researches have been done in Ayurveda to study the effectiveness of Ayurveda intervention in attention-deficit/ hyperactivity disorder (ADHD), one of the most common neurodevelopmental disorders in pediatric population. However, to date, no comprehensive systematic review has been conducted to assess the quality of clinical trials conducted and to determine the strength and safety of Ayurveda interventions in ADHD. Materials and methods: Published randomized clinical trials (RCTs), non-RCTs, and unpublished data on Ayurveda intervention in ADHD will be searched by using electronic databases such as the Cochrane Library, Pubmed, CENTRAL, Science Direct, AYUSH research portal, and other Indian databases. It involves the hand-searching of Ayurveda journals, and PG/PhD dissertations, if available, will also be utilized. The selection of study, data extraction, and synthesis will be done independently by reviewers. Standard tools will be adopted to assess the quality of trials. Risk of bias assessment will be performed by using Cochrane tool of risk of bias for RCTs and risk of bias in non-randomized studies of interventions (ROBINS-I) tool for non-RCTs. A narrative synthesis of findings from included studies will be described by providing treatment effect size. If sufficient data are available, the meta-analysis will be performed by using Review Manager. Outcome: The proposed protocol will act as a guiding tool for reproducing the same results in a transparent manner and to provide information to healthcare practitioners and policy makers.

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

“…These drugs have some major side effects, like methylphenidate can cause loose motions, anorexia, insomnia etc., whereas TCAs can cause anticholinergic side effects like dry mouth, weight gain, convulsions etc. [9] The results with these approved medications for ADHD are often unsatisfactory. FDA has approved Viloxazine (Qelbree) a new nonstimulant, nonscheduled drug to treat attentiondeficit/hyperactivity disorder (ADHD) in children and adolescents.…”

“…due to improper contact of senses with their objectives. [13] With different aspect knowledge of ADHD in Ayurveda. With ancient treasure of knowledge, there come newer dimensions for treating ADHD.…”

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for Mental Disorder (DSM-5) of American Psychiatric Association (APA), ADHD is characterized by persistent pattern of inattention or hyperactivity/impulsivity. [1] It is one of the most common neurodevelopmental disorders in children and adolescents which affect the social, learning and behavioral abilities, with increasing incident rate. The global estimated prevalence of this disorder is 5.29%, in India it ranges from 2-17%, [2] in Jaipur 9.7%, [3] 5-10% in children and 4-6% in adults.

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