A clinical trial to Evaluate Efficacy and Safety of Traditional Indian Medicine (TIM) of Siddha formulations in Children with Autism

INTERVENTION: Intervention1: Saraswathy Thailam, Amirtha Sanjeevini Chooranam & Kunjari Mezhugu: Saraswathy Thailam (External): Composition/ Ingredients: Sesbania aegyptiaca, Cow Milk, Sesame oil. Amirtha Sanjeevini Chooranam (Internal): Zingiber officinale, Elettaria cardamomum, Anacardium occidentale, Glycyrrhiza glabra, Piper nigrum, Terminalia chebula,Terminalia bellirica,Piper longum, Emblica officinalis,Jaggery,Cuminum cyminum. Kunjari Mezhugu (Internal):Composition/ Ingredients:Sulphur (Purified) and Honey. Control Intervention1: Saraswathy Thailam, Amirtha Sanjeevini Chooranam & Rasa Senthuram: Saraswathy Thailam (External): Composition/ Ingredients: Sesbania aegyptiaca, Cow Milk, Sesame oil. Amirtha Sanjeevini Chooranam (Internal): Zingiber officinale, Elettaria cardamomum, Anacardium occidentale, Glycyrrhiza glabra, Piper nigrum, Terminalia chebula,Terminalia bellirica,Piper longum, Emblica officinalis,Jaggery,Cuminum cyminum. Rasa Senthuram: Composition/ Ingredients: Mercury (purified) and Suphur (purified) CONDITION: Health Condition 1: F01‐F99‐ Mental, Behavioral and Neurodevelopmental disorders Health Condition 2: F989‐ Unspecified behavioral and emotional disorders with onset usually occurring in childhood and adolescence PRIMARY OUTCOME: Mean change in Indian Scale for Assessment of Autism (ISAA) score from baseline (Screening/ enrollment/ baseline visit, Day 0) to the end of the treatmentTimepoint: Mean change in Indian Scale for Assessment of Autism (ISAA) score from baseline (Screening/ enrollment/ baseline visit, Day 0) to the end of the treatment SECONDARY OUTCOME: Treatment emergent adverse events (TEAEs). ; ; Change in the Clinical Global Impression (CGI) score at the end of the treatment ; Timepoint: Visit 1 (Screening/ enrollment/ baseline visit, Day 0) ; ; Visit 2 (Telephonic visit, Day 24) ; ; Visit 3 (Day 48) ; ; Visit 4 (Telephonic visit, Day 72) ; ; Visit 5 (End of study visit, Day 96) ; INCLUSION CRITERIA: 1. Patients with DSM‐IV diagnosis of Autistic Disorder 2. Male or female patients Ë?5 years and Ë? 17 years of age 3. Patients with weight Ë? 15 kg 4. Patients on anticonvulsants used for treatment of seizure disorder with the dosage has been stable for 4 weeks and patient seizure free for at least 6 months 5. Clinical Global Impression Severity score of at least 4 or with 18 or greater score on the Irritability Scale of the Aberrant Behavior Checklist or with 5 total score on the Ritvo‐Freeman scale 6. Patients living with parents or caretaker 7. Patients whose parents are willing to give free written consent 8. Patients with language, hearing and vision compatible with the study measurements as judged by the investigator 9. No allergies to any of the ingredients of the study drug 10. Patients having no allergy to sulpha drugs 11. Patient are willing to follow the p