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Clinical Trial to Evaluate the Effectiveness of Shankhapushpi Syrup with or without Applied Behavior Analysis Therapy in Children with Autism Spectrum Disorder

Two Arm Open Label Prospective Clinical Study to Evaluate the Efficacy of Shankhapushpi Syrup with and without Applied Behavior Analysis Therapy in Autism Spectrum Disorder in Children - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084274
Enrollment
40
Registered
2025-04-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F840- Autistic disorder

Interventions

None listed

Sponsors

Post Graduate Institute of Ayurved DSRRAU Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Diagnosed cases of Autism satisfying DSM V criteria of both sexes 2 Patients with score above 70 in Indian Scale for assessment of Autism (ISAA) 3 Age between 3 to 16 years of both sexes.

Exclusion criteria

Exclusion criteria: 1 Patient with score below 70 in Indian Scale for assessment of Autism (ISAA) 2 ASD medications from any other system 3 Patients having mental retardation, cerebral palsy 4 Patients having presence of other organic or psychotic neurological disorder 5 Patients having pervasive developmental disorder 6 Patients having hearing and visual impairment 7 Patients having acute and chronic systemic illness such as renal diseases, hepatic dysfunction, juvenile diabetes mellitus etc 8 Patients having congenial disorders, genetic syndrome like fragile X syndrome, turner syndrome etc 9 Patients having progressive and non-progressive neuromuscular disorders

Design outcomes

Primary

MeasureTime frame
Shankhpushpi Syrup with and without Applied Behavior Analysis Therapy will be effective.Timepoint: 60 Days

Secondary

MeasureTime frame
1. Shankhpushpi Syrup with and without Applied Behavior Analysis Therapy will be helpful to improve quality of life of children suffering from ASD. 2. Change in ISAA score/ DSM V score.Timepoint: 60 Days

Countries

India

Contacts

Public ContactProf Dr Harish Kumar Singhal

Post Graduate Institute of Ayurveda Jodhpur

ayurharish14@gmail.com8619892143

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026