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临床试验/NCT06228157
NCT06228157撤回不适用

A Randomized Controlled Trial To Explore the Efficacy of Stellate Ganglion Block in Children With Autistic Disorder

Zeng Changhao1 个研究点 分布在 1 个国家开始时间: 2024年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Childhood Autism Rating Scale

研究概览

简要总结

The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:

Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated.

详细描述

Autistic Disorder in children is becoming increasingly more. The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:

Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosed as Autistic Disorder.
  • Aged between 6 years old and 12 years old.
  • No contraindications to stellate ganglion block.

排除标准

  • Other significant physical or neurodevelopmental disorders.
  • Other significant medical conditions

结局指标

主要结局

Childhood Autism Rating Scale

时间窗: day 1 and day 20

In the Childhood Autism Rating Scale, the rater observes the behavior of the child in specific situations and assigns scores based on a series of descriptive items. Each item is scored on a range of 0 to 4, with 0 indicating no abnormality and 4 indicating severe abnormality. The rater also considers the overall impression and severity of the child, resulting in a total score. The total score falls between 15 and 60, with higher scores indicating a higher level of autism severity.

次要结局

  • Children's Communication Checklist(day 1 and day 20)
  • Childhood Anxiety Sensitivity Index(day 1 and day 20)
  • Social Interaction Assessment Scale(day 1 and day 20)
  • Children's Depression Inventory(day 1 and day 20)

研究者

发起方
Zeng Changhao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zeng Changhao

Research Director

People's Hospital of Zhengzhou University

研究点 (1)

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