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Management of Autism Spectrum Disorder in children through Ayurveda as an add-on to conventional therapy

Management of Autism Spectrum Disorder in children through a comprehensive Ayurveda approach as an add-on to conventional therapy A randomized control clinical trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085035
Enrollment
80
Registered
2025-04-17
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

Central Council for Research in Ayurvedic Sciences, New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Participants of any gender in the age group greater than or equal 6 years to less than or equal to 15 years with a confirmed clinical DSM-5 diagnosis of autism spectrum disorder using the DSM-5 criteria. ISAA score in the range of 70 to 153 including mild viz. 70 to 106 and moderate viz 107 to 153 range of ASD. Participants whose parents are willing to provide informed written consent. Participants who are currently not on any medication. If on medication, they may be included after a washout period of 1 month. Concomitant medications may be allowed if the medicine is used for any acute illness which the investigator feels will not jeopardize the trial. Participants undergoing therapy at a therapy center.

Exclusion criteria

Exclusion criteria: Children with a history or diagnosis of any physical impairment or with any diagnosis of organic brain disorder or any other systemic disorder. Significant sensory (e.g., blindness, deafness, uncorrected hearing impairment) or motor (e.g., cerebral palsy) impairment. History of cardiovascular, pulmonary, endocrine diseases or other concurrent severe diseases. History of any other neurological disorder (Congenital anomalies of the brain and spinal cord, tumors of the brain and spinal cord, Hydrocephalus, Epilepsy, etc.) History of psychotic disorders of any type, bipolar disorder, schizophrenia and other psychiatric disorders such as anxiety disorders, major depressive disorder, etc. Participants on any medications psychotropic, anti-epileptic, stabilizers, benzodiazepines, etc.) Participants who have completed participation in any other clinical trial during the past 2 months. Any other condition that the investigator thinks may jeopardize the study.

Design outcomes

Primary

MeasureTime frame
Efficacy of comprehensive Ayurvedic treatment approach as an add-on to conventional therapy assessed through the changes in the score of the Autism Treatment Evaluation Checklist.Timepoint: 180 days

Secondary

MeasureTime frame
Efficacy of comprehensive ayurvedic treatment approach as an add-on to conventional therapy assessed through the changes in the scores of ISAA. Efficacy of comprehensive ayurvedic treatment approach as an add-on to conventional therapy assessed through the changes in the intellectual ability of the child using Wechsler Intelligence Scales for Children (WISC) Efficacy of comprehensive ayurvedic treatment approach as an add-on to conventional therapy in the daily living adaptive functioning assessed through Daily living skill subscale of the Vineland Adaptive Behaviour scales. Efficacy of comprehensive ayurvedic treatment approach as an add-on to conventional therapy assessed through the changes in the quality of life of parents using the quality of life in Autism Questionnaire (QoLA)Timepoint: 180 days

Countries

India

Contacts

Public ContactDr Vidyashree Anchan

Central Ayurveda Research Institute, Bengaluru

dr.anchan88@gmail.com8971859797

Outcome results

None listed

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