Spirulina syrup with risperidone for anxiety in young autistic children
Tests spirulina syrup added to risperidone for anxiety in children with autism.
Plain-language title generated from the registry record
Registry title: 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.
Key facts
- Where
- Yazd, IranSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 3 and 7 years old?
Source: NCT07060872, who can take part
Where in Iran
- Sanaz AlamdarYazd, IranNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shahid Sadoughi University of Medical Sciences and Health Services
- Trial code
- NCT07060872
- Record updated
- 11 July 2025
- Original description
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 (Risperidone tablets) plus Spirulina syrup, while the control group receives Risperidone plus a placebo. Anxiety is measured using the parent version of the Spence Children's Anxiety Scale (SCAS), which includes 38 items rated on a 4-point Likert scale. The questionnaire is administered online via the Porsline platform, and links are sent nightly via social media starting before treatment and continuing daily for one week after treatment initiation, then regularly over a 3-month follow-up period. Data will be analyzed using SPSS version 16. The SCAS consists of six subscales: separation anxiety, social anxiety, phobia, generalized anxiety, panic, and obsessive-compulsive symptoms.Read full original descriptionShow less
A Randomized Controlled Interventional Study on the Effects of Spirulina Supplementation on Anxiety in Children With Non-Idiopathic Autism
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 (Risperidone tablets) plus Spirulina syrup, while the control group receives Risperidone plus a placebo. Anxiety is measured using the parent version of the Spence Children's Anxiety Scale (SCAS), which includes 38 items rated on a 4-point Likert scale. The questionnaire is administered online via the Porsline platform, and links are sent nightly via social media starting before treatment and continuing daily for one week after treatment initiation, then regularly over a 3-month follow-up period. Data will be analyzed using SPSS version 16. The SCAS consists of six subscales: separation anxiety, social anxiety, phobia, generalized anxiety, panic, and obsessive-compulsive symptoms.
Inclusion: 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.
Exclusion: • 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.