Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2025-12-25 @ 3:17 AM
NCT ID:
NCT06911905
Eligibility Criteria:
Inclusion Criteria:
* Children aged between 2.5 and 6 years old
* Meeting the ASD diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* Meeting the ASD diagnostic criteria of the Diagnostic Observational Scale for Autism, Second Edition (ADOS-2）
* CARS total score ≥ 30
* Obtaining informed consent from the legal guardian
Exclusion Criteria:
* History of neurological diseases such as epilepsy
* History of congenital diseases such as hearing, visual impairment
* Diagnosed with metabolic disorders such as hypophosphatemic rickets
* Diagnosed with genetic or chromosomal abnormalities
* Brain structural abnormalities detected by MRI which required surgical intervention
* Currently participating in other clinical trials
* Received any new intervention within 8 weeks prior to enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Months
Maximum Age:
72 Months
Study:
NCT06911905
Study Brief:
Protocol Section:
NCT06911905