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IRCT20181111041611N10 IRCT 2026-10-17 Kermanshah University of Medical Sciences The effect of nano-curcumin supplementation on the severity of behavioral symptoms in children with autism spectrum disorder: A randomized controlled clinical trial. The effect of nano-curcumin supplementation on the severity of behavioral symptoms in children with autism spectrum disorder: A randomized controlled clinical trial. 2026-11-27 anticipated 54 Pending https://irct.ir/trial/92845 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: The study presents no noteworthy unique characteristics, Randomization description: Stratified block randomization will be performed to assign participants to the intervention and placebo using the website www.randomization.com. Stratification will be based on age categories (6-8 years and 9-12 years) to ensure age balance between groups. within each stratum, patients will be randomly allocated to either group in a 1:1 ratio using a block size of 4. To ensure allocation concealment, the randomization sequence will be generated by an independent researcher outside of the study team and placed in sequentially Numbered, Opaque, Sealed Envelopes, which will be opened only after participant enrollment and signed informed consent, Blinding description: This will be a double-blind study. Participants/parents, outcome assessors, and data analysts will be blinded to group allocation.Nano-curcumin and placebo capsules will be identical in color, shape, size, weight, odor, taste, and packaging. Packaging and coding will be performed by the pharmaceutical company or a third party outside the research team. The codes are kept by an independent person until data analysis is completed. 3 Autism. Intervention 1: Intervention group: Oral nano-curcumin capsule 40 mg (Sina Curcumin, Exir Nano Sina, Iran), one capsule twice daily (every 12 hours) for 12 weeks. Each capsule contains 40 mg nano-curcumin; total daily dose is 80 mg. Intervention 2: Control group: Control/placebo group: Identical placebo capsule in packaging, color, shape, size, weight, odor, and taste, one capsule twice daily for 12 weeks. Placebo is provided by the same manufacturer. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there is no more information available
public Dr mehnoosh samadi
Kermanshah, Isar square, next to Farabi hospital, faculty of food science and food industry
Kermanshah Iran (Islamic Republic of) 6719851552 +98 912 601 6296 mehnoosh_samadi@yahoo.com Kermanshah University of Medical Sciences scientific Dr mehnoosh samadi
Kermanshah, Isar square, next to farabi hospital, faculty of food science and food industries
Kermanshah Iran (Islamic Republic of) 6719851552 +98 912 601 6296 mehnoosh_samadi@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of autism spectrum disorder by a psychiatrist based on DSM-5 criteria Age 6–12 years Stability of behavioral symptom severity over the past three months based on medical records Ability to take oral supplements Written informed consent from parents or legal guardian 6 years 12 years Both Presence of co-occurring neurodevelopmental disorders, such as uncontrolled epilepsy or other neurological disorders affecting the assessment of study outcomes. Having chronic metabolic, hepatic, or gastrointestinal diseases that could affect the safety of nano-curcumin supplement consumption or the study results. History of hypersensitivity or adverse reaction to curcumin or other ingredients in the supplement being used. Concomitant use of supplements or medications affecting behavioral symptoms or containing curcumin within the past three months. Inability of parents to cooperate in carrying out the study procedures and completing the required assessments. F84.0 Autistic disorder Treatment - Other Treatment - Other Intervention group: Oral nano-curcumin capsule 40 mg (Sina Curcumin, Exir Nano Sina, Iran), one capsule twice daily (every 12 hours) for 12 weeks. Each capsule contains 40 mg nano-curcumin; total daily dose is 80 mg. Control group: Control/placebo group: Identical placebo capsule in packaging, color, shape, size, weight, odor, and taste, one capsule twice daily for 12 weeks. Placebo is provided by the same manufacturer. Change in the severity of behavioral symptoms in children with autism (Aberrant Behavior Checklist total score) from baseline to the end of the study. Timepoint: Baseline,1month later, and end of study. Method of measurement: Aberrant Behavior Checklist (ABC) questionnaire; ADOS-2 for baseline assessment if needed. • Social and communication functioning. Timepoint: Baseline, 1month later, and end of study. Method of measurement: SRS-2 questionnaire. Repetitive and stereotypical behaviors. Timepoint: Baseline, 1month later, and end of study. Method of measurement: ABC(Aberrant Behavior Checklist) and SRS-2(Social Responsiveness Scale) repetitive behavior subscale. Irritability and challenging behaviors. Timepoint: Baseline, 1month later, and end of study. Method of measurement: ABC (Aberrant Behavior Checklist) subscale. Children's sleep quality. Timepoint: Baseline, 1month later, and end of study. Method of measurement: Children's Sleep Habits Questionnaire (CSHQ). Hyperactivity. Timepoint: Baseline, 1month later, and end of study. Method of measurement: CBCL (Child Behavior Checklist) subscale. Food intake. Timepoint: Baseline, 1month later, and end of study. Method of measurement: 3-Day stimated food record. Hieght. Timepoint: Baseline, 1month later, and end of study. Method of measurement: Non-stretch tape measure. Wieght. Timepoint: Baseline, 1month later, and end of study. Method of measurement: Digital scale. Kermanshah University of Medical Sciences Approved 2026-06-06 Ethics Committee of Kermanshah University of Medical Sciences Building No. 2, Research Council of Kermanshah University of Medical Sciences (KUMS), Shahid Beheshti Boulevard, Kermanshah, Iran. Kermanshah Kermanshah Iran (Islamic Republic of)