Health Condition 1: F840- Autistic disorder
Conditions
Interventions
None listed
Sponsors
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
| Measure | Time 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
| Measure | Time 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
Central Ayurveda Research Institute, Bengaluru