Health Condition 1: F840- Autistic disorder
Conditions
Interventions
Intervention1: Hopantanic aacid: Hopantenic acid (30 mg/kg/day) in syrup formulation.
Intervention2: Folinic acid: Folinic acid (45mg/day) in tablet form
Control Intervention1: Placebo: Placebo , matc
Sponsors
Butterfly Learnings co Bombay Autism Services Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 2 to 12 years Confirmed ASD diagnosis Stable therapies for more than 4 weeks Informed consent and child assent as appropriate
Exclusion criteria
Exclusion criteria: Patients who are unwilling to provide the consent Major co-morbid psychiatric disorders (e.g., schizophrenia, bipolar) Significant neurological disease (e.g., uncontrolled epilepsy) Major systemic illnesses (cardiac, hepatic, renal, etc.) Severe sensory impairments Known allergies to study drugs Use of folinic acid in prior 2 weeks Inability to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VB-MAPP: Change in developmental language and communication milestones from baseline to 3 months. CARS-2: Change in clinician-rated autism symptom severity at 3 months. Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Sonam Kothari
Butterfly Learnings c/o Bombay Autism Services Private Limited
Outcome results
None listed