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Clinical Trials/CTRI/2024/05/067754
CTRI/2024/05/067754CompletedPhase 2

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.

National Institute of Siddha1 site in 1 country20 target enrollmentStarted: June 1, 2024Last updated:

Trial Snapshot

Phase
Phase 2
Status
Completed
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

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr M Keerthana

National Institute of Siddha

Study Sites (1)

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