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
Conditions
Interventions
Intervention1: Saraswathy Thailam, Amirtha Sanjeevini Chooranam & Kunjari Mezhugu: Saraswathy Thailam (External): Composition/ Ingredients:
Sesbania aegyptiaca,
Cow Milk,
Sesame oil.
Amirtha Sanjeevin
Sponsors
Manushyaa Blossom Private limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with DSM-V diagnosis of Autistic Disorder 2. Male or female patients Ã?Æ? 5 years and Ã?â?? 17 years of age 3. Patients with weight Ã?Æ? 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 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 protocols requirements
Exclusion criteria
Exclusion criteria: 1. Patients below the age Ã?â?? 5 years and Ã?Æ? 17 years of age 2. Patients who is not willing to participate in the study 3. Patients with IQ below 18 months 4. Patients with an evidence of hypersensitivity to any of study product components 5. Patients with history of neuroleptic malignant syndrome 6. Patents with DSM-V diagnosis of Pervasive Developmental Disorder other than Autistic Disorder 7. Patients with a significant concomitant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, or unstable seizure disorder 8. Patients with weight less than 15 kg 9. Patients requiring initiation of a major change in psychosocial intervention (including investigational) within 4 weeks prior to screening 10. Patients with a risk of suicidal behavior 11. Patients with medical history of alcohol or substance abuse/dependence 12. Patient has participated in another clinical study involving another investigational agent within 4 weeks of the start of this trial, or is planning participation in another clinical trial during the current study duration 13. Patient with known hypersensitivity to individual ingredients of the study drug 14. Patients with presence of any symptom indicating serious or malignant disease 15. Patient having a Medical or social condition that would, in the opinion of the investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactMr Vairamuthu Ammaiyappan
Sanjeev Biomedical Research Centre
Outcome results
None listed