Clinical Evaluation of the Efficacy of Takradhara in Attention Deficit Hyperactive Disorder
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Improvement in attention Decrease in hyperactivity and impulsivity
Study Overview
Brief Summary
The present study aims to evaluate the efficacy of Takradhara in Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a common neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity, leading to academic, behavioral, and social difficulties in children. Takradhara, a Ayurvedic therapy involving the continuous pouring of medicated buttermilk over the forehead for 7days followed by Brahmi ghrita oral administration for 30 days will helps to calm, reduce stress and enhance concentration in children. The sample will be collected from our hospital of both gender, age 6yrs to 16yrs. Those who fulfil the inclusive will be included in the study. Sample size is 20. This study is designed to assess its role as in ADHD.The primary outcome will focus on the reduction of ADHD symptoms (inattention, hyperactivity, impulsivity) assessed using standardized rating scales. The secondary outcomes include improvement in cognitive functions, behavior, quality of life
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 6.00 Year(s) to 16.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1 Children aged between 6-16 years of age 2 Children fulfilling the DSM-V criteria for diagnosis of ADHD.
- •3 Parents who are willing for treatment and giving concern.
Exclusion Criteria
- •1 Children under other medications or interventions such as behavior therapy are excluded from the study.
- •2 Children with mild to severe mental retardation conduct disorders, 3 Pervasive disorder and other Psychotic disorders are excluded.
- •4 Children with chronic ailments like tuberculosis, malignancy etc.are excluded.
Outcomes
Primary Outcomes
Improvement in attention Decrease in hyperactivity and impulsivity
Time Frame: After 90 days
Secondary Outcomes
- Improvement in concentration and academic school performance(after 90 days)
Investigators
Dr Vijayalaxmi Benakatti
BLDEAs AVS Ayurveda Mahavidyalaya Hospital Research Centre Vijayapura