NCT07060872Not yet recruiting
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.
A Randomized Controlled Interventional Study on the Effects of Spirulina Supplementation on Anxiety in Children With Non-Idiopathic Autism
Source: ClinicalTrials.gov · Last updated 11 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 82 (estimated)
- First submitted
- 2 Jul 2025
- Start date
- 7 Jul 2025
- Primary completion date
- 15 Sept 2025
- Lead sponsor
- Shahid Sadoughi University of Medical Sciences and Health Services
- Diseases
- Autism
- NCT number
- NCT07060872
What you commit to
- Study type: Interventional
- Planned participants: 82
- From 7 Jul 2025 to the primary completion date, 15 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- • 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
Who the study is looking for
- 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
Age in the registry: 3 years to 7 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sanaz Alamdar Coordinator of this site? Confirm its status | Yazd | Iran | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.