Clinical Evaluation of Siddha Management of Muthu Parpam with Brahmi Nei (internal) and Siriya Bringamalaha Thailam (oil bath) for Alathidu Sanni (Attention Deficit Hyperactivity Disorder) in Children.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- National Institute of Siddha
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- To assess the effectiveness of Muthu Parpam & Brahmi Nei (internal) and Siriya Bringamalaha Thailam (oil bath) for the management of Alathidu Sanni (Attention Deficit Hyperactive Disorder) in children by using Conner’s investigator rating scale and conner’s parent rating scale.
Study Overview
Brief Summary
INTRODUCTION: This is an open non randomized clinical trail to determine the effectiveness of Muthu Parpam with Brahmi nei (internal) and Siriya Bringamalaha Thailam (oil bath) for the management of Alathidu Sanni (Attention Deficit Hyperactive Disorder) in children. Attention-deficit hyperactivity disorder (ADHD) is the most common neurobehavioral illness of childhood, one of the most prevalent chronic health issues impacting school-aged children. It is characterized by inattention, including increased distractibility and difficulty sustaining attention, poor impulse control and decreased self-inhibitory capacity and motor over activity and motor restlessness. Development of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria leading to the diagnosis of ADHD occurred mainly in field trials with children 5-12 years of age. The global prevalence of ADHD is 7.6% of children aged 3-12 years in which 33.2% of children are inattentive subtype, 30.3% are hyperactive impulsive subtype and 31.4% are combined type. MATERIALS****AND METHODS: A total of 20 patients within age limit of 5-12 years willing to participate in the study by signing consent and assent form will be enrolled in the study. Both male and female children are included. RESULTS AND DISCUSSION: Effectiveness of the trial drug will be measured by reduction of clinical symptoms by using CONNERS PARENT RATING SCALE and the results will be statistically analysed.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 5.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Meets the diagnostic symptoms of (Any of the three or above)
- •Lack of concentration
- •Talking incessantly
- •Blurting things out
- •Frequent jumping from one task to another
- •Being easily distracted
- •Hyperactivity
- •Trouble sitting still
- •Inability to react to other people’s emotions or feelings.
Exclusion Criteria
- •H/O Seizure disorder
- •K/C/O Autistic spectrum disorder
- •Auditory and visual processing disorder.
- •Neurodegenerative disorder.
- •Post encephalitic disorder.
Outcomes
Primary Outcomes
To assess the effectiveness of Muthu Parpam & Brahmi Nei (internal) and Siriya Bringamalaha Thailam (oil bath) for the management of Alathidu Sanni (Attention Deficit Hyperactive Disorder) in children by using Conner’s investigator rating scale and conner’s parent rating scale.
Time Frame: Screening - 3 months | Patient Enrolment - 6 months | Trial Drug - 10 months | Data Analysis - 2 month | Follow up - 3 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr M Keerthana
National Institute of Siddha
