Clinical Trial

Effect of Increasing Total Antioxidant Capacity in Autism Spectrum Disorder

Study acronym: TACASD
Enrolling by Invitation
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Record status
This record was last updated October 4, 2024 (before its estimated January 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
This double-blind, randomized, controlled trial (RCT) has the aim to evaluating the effectiveness of increasing Total Antioxidant Capacity (TAC) as add-on intervention in two cohorts of patients with Autism Spectrum Disorder (ASD) who have received Risperidone (0.02-0.06 mg/KgBW) and Behavior Therapy as maintenance therapy. Both groups will receive placebo pill or Vitamin E and C pill using randomization. Clinical Symptoms, Aberrant Behavior and Quality of Life in Children with ASD will be assessed after 12 weeks of treatment in this study. Primary outcome measures of efficacy is Aberrant Behavior Checklist- Irritability (ABC-Irritability) and Secondary outcome measures include Childhood Autism Rating Scale (CARS), Clinical Global Impression Scale - Improvement (CGI-I), The PedsQL and The WHOQOL BREF.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-10-01.
Trial Details
NCT Number NCT06623227
Lead Sponsor Rinvil Renaldi
Collaborators: University of Modena and Reggio Emilia, Indonesia University, RSUP Dr. Wahidin Sudirohusodo
Conditions Autism Spectrum Disorder
Enrollment 50 participants
Start Date 2024-09-28
Primary Completion 2025-01-31 (estimated)
Study Completion 2025-06-30 (estimated)
Updated on ClinicalTrials.gov 2024-10-04