A prospective, interventional, randomised, two-arm, single centre study to evaluate the effect of ten-on-ten syrup on children with attention deficit hyperactivity disorder (ADHD).

Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by persistent pattern of inattention and/or hyperactivity-impulsivity, interfering with functioning and development. The global prevalence rate of ADHD is around 5–10% . Children with ADHD have significant adverse outcomes such as educational problems, difficult peer relationships and increased rates of motor vehicle accidents, accidental injuries, and substance misuse. Since past two decades, the research on ADHD in western population has been accelerating, yet research on ADHD in India is on the rise only since the last decade. Ten-on-ten syrup is such alternative treatment which is an over-the-counter product, with no alcohol, no sedation, non-habit forming brain wellness tonic which is free from heavy metals. The objective is to evaluate improvement in signs and symptoms of ADHD after using ten-on-ten syrup based on Vanderbilt Assessment Scale-parent version. This study is a prospective, interventional, randomised, two-arm, single centre study. The inclusion criteria for the study is children (of all genders and any religion) aged between 6-12 years who are diagnosed with mild to moderate ADHD. Exclusion criteria for the study includes, children less than 6 years and more than 12 years, children with Epilepsy and taking anti-epileptic medications. children with severe comorbid conditions like oppositional defiant disorder, conduct disorder, substance abuse, anxiety disorder, history of hypersensitivity or food allergy to components of omega 3/6, herbal supplements shall be elicited on medical history, Children taking anticoagulant medications like warfarin or aspirin and children with chronic systemic disease or other major psychiatric disorders. The duration of the study is six months. Study Intervention which is the Ten-on-ten syrup will be given to ADHD diagnosed children for duration of 6 months. Data parameters for the study include demographic details, physical assessment, Vanderbilt Assessment parent version scale and follow up scale-parent version scores. The outcome of the study is to evaluate the improvement in signs and symptoms of ADHD assessed using Vanderbilt assessment scale-parent version.