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Assessment of Quercetin on adult patients with autism

Assessment of the Efficacy of Quercetin on Adult Patients with Autism Spectrum Disorder: A Randomized, Triple-Blind, Placebo-Controlled Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241214064050N1
Enrollment
52
Registered
2024-12-23
Start date
2025-01-04
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder. Autistic disorder

Interventions

Intervention 1: Intervention group: The group receiving oral quercetin capsules at a dose of 500 mg for 60 consecutive days, provided by Noavaran Darooee Yaran Pharmaceutical Company. Intervention 2:

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 56 Years

Inclusion criteria

Inclusion criteria: Patient age between 16 years and 0 months to 55 years and 11 months Confirmation of the diagnosis by a psychiatrist based on DSM-5 Complete physical examination Ability to understand and speak Persian easily Ability to read and understand the consent form completely and, if not possible, the legal guardian of the person should read and sign the form Score on the Clinical Global Impression-Severity (CGI-S) test above 4 in screenings Intelligence score on the Stanford-Binet test above 65

Exclusion criteria

Exclusion criteria: Patients in the acute phase of psychiatric illness or with thoughts of death and suicide Having a history of neurological diseases, seizures, and head trauma People with a history of neurological or metabolic disease that affects sensory and motor function, etc. Pregnant and lactating women History of allergy to quercetin and other flavonoids People with a history of chronic treatment with quercetin

Design outcomes

Primary

MeasureTime frame
Score of Change in clinical global Impressions-Improvement and Severity test questionnaire. Timepoint: Complete the questionnaires on the day of the study, on day 30 of the study, and on day 60 of the study. Method of measurement: The CGI-S questionnaire, with which the psychiatrist scores the severity of the individual's illness and improvement based on her/his clinical diagnosis.

Secondary

MeasureTime frame
Ritvo questionnaire score. Timepoint: Study start date and study days 30 and 60. Method of measurement: In the Ritvo questionnaire, the researcher and psychiatrist ask 80 questions about the patient's personality traits. Based on the selection of each option in each question, the individual receives a score from one to four, and the sum of these scores indicates the score of this questionnaire at different points in time.;Autism Quotient questionnaire score. Timepoint: Study start date and study days 30 and 60. Method of measurement: In the Autism Quotient Questionnaire, the researcher and psychiatrist ask the patient 50 questions about behaviors consistent with autism. Based on the selection of each of the options of agreeing or disagreeing with each question, the individual receives a score, and the sum of these scores indicates the score of this questionnaire at certain points in time.;World Health Organization-Quality of Life questionnaire score. Timepoint: Study start date and study days 30 and 60. Method of measurement: In the world health organization quality of life questionnaire, the researcher asks 26 questions regarding the assessment of the quality of life of the autistic patient. Based on the selection of each option in each question, the individual receives a score regarding his or her satisfaction with life, and the sum of these scores shows the score of this questionnaire at different points in time.;Social responsiveness scale -social motivation subscale questionnaire score. Timepoint: Study start date and study days 30 and 60. Method of measurement: In the Social Responsiveness Scale - Social Motivation Subscale questionnaire, the researcher asks 65 questions about improving social symptoms in adults with autism. Based on the selection of each option in each question, the individual receives a score regarding their behavior in society, and the sum of these scores shows the score of this questionnaire at different points in time.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAnahid Rezaeefar

Tehran University of Medical Sciences

anahidre.9776@yahoo.com+98 21 5541 9151

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026