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Clinical Trial NCT07060872 (Autism Anxiety) for Age 3 to 7 Years, Mild Autism Spectrum, no Other Illness or Disorder is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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the Effect of Formulation on Anxiety in Autist Childre A Randomized Controlled Trial Assesses Spirulina Syrup Plus Risperidone in Children With Non-idiopathic Autism. Anxiety is Measured Using the SCAS (Parent Version) Via Daily Online Surveys for One Week and Throughout a 3-month Follow-up Period. (Autism Anxiety) 82 Randomized Pediatric

Not yet recruiting
Clinical Trial NCT07060872 (Autism Anxiety) is an interventional study for Age 3 to 7 Years, Mild Autism Spectrum, no Other Illness or Disorder and is currently not yet recruiting. Enrollment is planned to begin on July 7, 2025 and continue until the study accrues 82 participants. Led by Shahid Sadoughi University of Medical Sciences and Health Services, this study is expected to complete by October 1, 2025. The latest data from ClinicalTrials.gov was last updated on July 11, 2025.
Brief Summary
The aim of this study is to evaluate the effect of a Spirulina syrup formulation on reducing anxiety in children with non-idiopathic autism. Participants are referred to a private clinic and assessed by a pediatric neurology subspecialist to confirm the diagnosis. Informed consent is obtained from the parents. Patients are randomly assigned to two groups. The intervention group receives standard treatment (Risperidon...Show More
Detailed Description
Detailed Description

Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by persistent challenges in social interaction, communication, and restricted, repetitive patterns of behavior, interests, or activities. According to the latest data from the U.S. Centers for Disease Control and Prevention (CDC), approximately 1 in 54 children aged 8 years is diagnosed with ASD. The exact etiology of...

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Official Title

A Randomized Controlled Interventional Study on the Effects of Spirulina Supplementation on Anxiety in Children With Non-Idiopathic Autism

Conditions
Age 3 to 7 YearsMild Autism Spectrumno Other Illness or Disorder
Other Study IDs
  • Autism Anxiety
  • IR.SSU.REC
NCT ID Number
NCT07060872
Start Date (Actual)
2025-07-07
Last Update Posted
2025-07-11
Completion Date (Estimated)
2025-10-01
Enrollment (Estimated)
82
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Autism
Anxiety
Spirulina
Pharmaceutical supplement
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSpirulina Syrup
* Spirulina Syrup * Risperidone
Spirulina Syrup
A natural dietary supplement derived from Spirulina algae, administered orally as a syrup formulation. Used as an adjunct therapy to assess its potential effect on reducing anxiety symptoms in children with non-idiopathic autism. Dosage and duration are standardized according to study protocol.
Risperidone
Risperidone
Placebo ComparatorPlacebo Syrup
* Placebo Syrup * Risperidone
Placebo Syrup
Placebo Syrup
Risperidone
Risperidone
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in anxiety symptoms based on the Spence Children's Anxiety Scale (Parent Version) total score
Anxiety symptoms will be assessed using the Spence Children's Anxiety Scale (SCAS) - Parent Version, a 38-item validated tool. Total score changes will be used to evaluate treatment efficacy.
From baseline to 3 months after treatment initiation
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in subscale scores of SCAS (e.g., separation anxiety, social anxiety, generalized anxiety, etc.)
SCAS subscale scores will be analyzed to determine which domains of anxiety are most affected by Spirulina supplementation.
From baseline to 3 months after treatment initiation
Participation Assistant
Eligibility Criteria

Eligible Ages
Child
Minimum Age
3 Years
Eligible Sexes
All

  • Children diagnosed with non-idiopathic autism, confirmed by a pediatric neurology subspecialist

    • Age range: \[3 to 7 years\]
    • Parental informed consent obtained
    • Ability to complete online anxiety questionnaires with parental assistance

  • • Presence of other major neurological or psychiatric disorders

    • Known allergy or intolerance to Spirulina or Risperidone
    • Participation in other clinical trials within the past 3 months
    • Severe medical conditions that contraindicate the use of study medications
Shahid Sadoughi University of Medical Sciences and Health Services logoShahid Sadoughi University of Medical Sciences and Health Services
Study Responsible Party
Sanaz Alamdar, Principal Investigator, Graduate Student, Shahid Sadoughi University of Medical Sciences and Health Services
Study Central Contact
Contact: Sanaz Alamdar, M.s, +989132738977, [email protected]
1 Study Locations in 1 Countries
Sanaz Alamdar, Yazd, 8917634787, Iran