Autistic Spectrum Disorder. Autistic disorder
Conditions
Interventions
Intervention 1: Twenty-eight participants will be randomly assigned to the intervention group and will receive Attensaf capsules, a herbal supplement containing standardized saffron extract, for 8 wee
Sponsors
Sanandaj University of Medical Sciences
Eligibility
Sex/Gender
All
Age
3 Years to 12 Years
Inclusion criteria
Inclusion criteria: Age: Patients must be between 3 to 12 years old. Diagnosis: A confirmed diagnosis of Autism Spectrum Disorder (ASD) based on DSM-5 criteria by a psychiatrist. Consent: Written informed consent from parents or legal guardians for participation in the study Follow-up Ability: The ability to attend regular follow-ups at the clinic for medication doses and periodic evaluations.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Severe Comorbid Disorders: Presence of other severe psychiatric disorders such as schizophrenia or bipolar disorder Medication Use: Use of other medications that may interact with Attensaf Drug Sensitivity: History of allergy or severe reaction to saffron or any components of Attensaf capsules. Specific Medical Conditions: Presence of medical conditions that may limit or pose a risk to participation in the study, such as severe liver or kidney disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Social interaction domain scores of the GARS-3 in children diagnosed with ASD. Timepoint: Baseline, weeks 2, 4, 6, and 8. Method of measurement: Assessment of changes in social interactions in children with Autism Spectrum Disorder using the Gilliam Autism Rating Scale, Third Edition, based on evaluations by parents and specialists at baseline, weeks two, four, six, and eight. | — |
Secondary
| Measure | Time frame |
|---|---|
| Scores on the child and family health-related quality of life questionnaire assessed at baseline, weeks 2, 4, 6, and 8. Timepoint: Baseline, weeks 2, 4, 6, and 8. Method of measurement: Improvement in quality of life: Measured using the Pediatric Quality of Life Inventory at baseline, weeks two, four, six, and eight.Improvement in academic and social functioning: Assessed through reports from teachers and parents at designated time points.Safety and tolerability of the drug: Evaluated through clinical examinations and parental reports throughout the study. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSoleiman Mohammadzadeh
Sanandaj University of Medical Sciences
Outcome results
None listed