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.
Launched by SHAHID SADOUGHI UNIVERSITY OF MEDICAL SCIENCES AND HEALTH SERVICES · Jul 10, 2025
Trial Information
Current as of July 14, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether adding Spirulina syrup, a natural supplement, to the usual medication Risperidone can help reduce anxiety in young children aged 3 to 7 who have a mild form of autism that is not caused by an unknown reason (non-idiopathic autism). Anxiety will be measured by parents using a simple online questionnaire that looks at different types of anxiety symptoms, such as fear of being apart from parents, social worries, and panic feelings. The study will compare two groups: one receiving both Spirulina syrup and Risperidone, and the other receiving Risperidone with a placebo (a harmless liquid without Spirulina).
To take part, children must have a confirmed diagnosis of this type of autism from a specialist and their parents must agree to participate. Families will be asked to help their child complete daily online surveys about anxiety symptoms for one week after starting treatment and then regularly for three months. This helps the researchers understand if Spirulina syrup makes a difference over time. Children with other serious health problems or allergies to the study treatments will not be eligible. This trial is not yet recruiting participants, but it aims to find out if this new combination can better support children with autism in managing anxiety.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • • 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
About Shahid Sadoughi University Of Medical Sciences And Health Services
Shahid Sadoughi University of Medical Sciences and Health Services is a leading academic institution dedicated to advancing healthcare through innovative research and education. Located in Yazd, Iran, the university plays a pivotal role in the development of medical sciences by conducting rigorous clinical trials aimed at improving patient outcomes and enhancing public health. With a commitment to excellence, the institution fosters collaboration among researchers, healthcare professionals, and community stakeholders, ensuring that its research initiatives are aligned with the latest advancements in medical science and meet the pressing health needs of the population.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Yazd, , Iran, Islamic Republic Of
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported