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临床试验/NCT07060872
NCT07060872尚未招募不适用

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

Shahid Sadoughi University of Medical Sciences and Health Services1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2025年7月7日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
82
试验地点
1
主要终点
Change in anxiety symptoms based on the Spence Children's Anxiety Scale (Parent Version) total score

研究概览

简要总结

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.

详细描述

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 ASD remains unclear, but both genetic and environmental risk factors-including advanced parental age, prenatal infections, and complications during pregnancy-have been implicated.

ASD presents with a heterogeneous range of symptoms and severity. Some children may demonstrate intellectual disability, language delays, sensory sensitivities, stereotyped behaviors, and resistance to change. Others may show above-average intelligence, articulate speech, and creative talents. In addition to core symptoms, individuals with ASD often suffer from comorbidities such as anxiety, depression, gastrointestinal disturbances, and sleep problems. These comorbid conditions can significantly impair quality of life and increase the burden on families, necessitating a multidisciplinary treatment approach.

While no definitive cure for ASD currently exists, evidence-based interventions such as behavioral therapies, educational programs, and pharmacological treatments aim to manage core symptoms and associated conditions. Common pharmacologic interventions include antipsychotic medications such as risperidone to manage irritability and aggression. However, these medications often come with undesirable side effects. Consequently, there is a growing interest in complementary and alternative medicine (CAM) to support children with ASD.

Recent studies suggest that 50-95% of families with ASD-affected children explore CAM therapies, including herbal medicine, dietary supplements, and special diets. Despite limited empirical evidence, several traditional remedies have shown promise in mitigating symptoms or improving physiological functions in ASD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
3 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • • 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

研究组 & 干预措施

Spirulina Syrup

Experimental
  • Spirulina Syrup
  • Risperidone

干预措施: Spirulina Syrup (Dietary Supplement)

Spirulina Syrup

Experimental
  • Spirulina Syrup
  • Risperidone

干预措施: Risperidone (Drug)

Placebo Syrup

Placebo Comparator
  • Placebo Syrup
  • Risperidone

干预措施: Placebo Syrup (Dietary Supplement)

Placebo Syrup

Placebo Comparator
  • Placebo Syrup
  • Risperidone

干预措施: Risperidone (Drug)

结局指标

主要结局

Change in anxiety symptoms based on the Spence Children's Anxiety Scale (Parent Version) total score

时间窗: From baseline to 3 months after treatment initiation

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.

次要结局

  • Change in subscale scores of SCAS (e.g., separation anxiety, social anxiety, generalized anxiety, etc.)(From baseline to 3 months after treatment initiation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sanaz Alamdar

Graduate Student

Shahid Sadoughi University of Medical Sciences and Health Services

研究点 (1)

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