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To find The effect Of Balasohaladi Sirolepam as compared to Behavioral Therapy in children with autism and hyper activity aged 3 TO 12 years

A Non randomised controlled trial on the effect of Balasohaladi Sirolepa as compared to behavioral therapy in hyperactivity associated with Autism spectrum disorder in children aged 3 to 12 years . - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072205
Enrollment
32
Registered
2024-08-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Anju Sreedharan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.subject of both sex of age group 3 to 12 years satisfying DSM criteria for ASD and having a CARS score above 30. 2.subject having hyperactivity in association with ASD as assessed by ASD as assessed by ADHD T2 scale&VADDP RS

Exclusion criteria

Exclusion criteria: 1.clinically diagnosed case of PDD ,Rett syndrome,Asperger syndrome,childhood disintegrative disorder,PDD-NOS(not otherwise specified) 2.clinically diagnosed case of other developmental disorders and neurological disorders. 3.children with recurrent respiratory tract infections,and intractable epilepsy.The exclusion is based on clinical features,history of illness along with available investigation report

Design outcomes

Primary

MeasureTime frame
To assess Reduction in hyperactivity in asd children among age group 3 to 12 years asseessed by tools Such as ADHDT2,VADPRS.Timepoint: 28 days and a follow up of 1 month—

Secondary

MeasureTime frame
To study changes in severity of ASD, assessed by ATEC ,CARSTimepoint: 28 Days , followup of 1 month—

Countries

India

Contacts

Public ContactANJU SREEDHARAN

Government ayurveda college,Thiruvananthapuram

doctoroshni@gmail.com9447006585

Outcome results

None listed

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