A randomised single blind placebo controlled comparative clinical study to evaluate the efficacy of Bodhi Satva Sukshma Aushadhi in the management of Attention Deficit Hyperactivity Disorder in children.
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Reduced DSM-5 Score
Study Overview
Brief Summary
Attention Deficit Hyperactivity Disorder (ADHD) is the most common neurobehavioral disorder of childhood and can affect the academic achievement, well being and social interactions of the children. The recent COVID-19 pandemic along with quarantine, social isolation and increased screen time with the usage of smartphone for a longer period of time has disproportionately and adversely affected a generation of children with ADHD.
The objective of this study is to clinically evaluate the effectiveness of Bodhi Satva Sukshma Aushadhi in the management of Attention Deficit Hyperactivity Disorder in children. 60 patients from age 5-12 years fulfilling the DSM-5 criteria will be selected and enrolled for the study. Randomization of the selected patients will be done into two groups. Group A - 30 patients and Group B - 30 patients. Since this is a single blind study both groups will be given medicines in coded bottles. Group A will be orally administered with Bodhi Satva Sukshma Aushadhi for 60 days and Group B will be orally administered with Placebo pills for 60 days. Four consecutive follow ups will be taken in every 15 days and observations in DSM-5 scores will be recorded.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 5.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children aged between 5-12 years of age
- •Children having signs and clinically diagnosed for Attention Deficit Hyperactivity Disorder ADHD as per DSM-5 Criteria.
Exclusion Criteria
- •Children not fulfilling the DSM-5 Criteria for diagnosis of Attention Deficit Hyperactivity Disorder ADHD.
- •Known case of Cerebral palsy, mental retardation and epilepsy.
- •Known case of hearing deficit.
- •Children with obvious congenital anomalies like Cleft Palate, Coronary Heart Disease.
- •Known case of major systemic disorders and metabolic disorders.
Outcomes
Primary Outcomes
Reduced DSM-5 Score
Time Frame: After every 15 Days (From 0th, 15th, 30th, 45th and 60th day).
Secondary Outcomes
- Reduced Inattention, Hyperactivity and Impulsivity(After every 15 Days (From 0th, 15th, 30th, 45th and 60th day).)
Investigators
Dr Shubham Neelkanth Patil
D.Y.Patil Deemed to be University, School of Ayurveda, Nerul, Navi Mumbai