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Clinical Trials/NCT06228157
NCT06228157
Withdrawn
N/A

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

Zeng Changhao1 site in 1 countryFebruary 5, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autistic Disorder
Sponsor
Zeng Changhao
Locations
1
Primary Endpoint
Childhood Autism Rating Scale
Status
Withdrawn
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 5, 2024
End Date
May 15, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Zeng Changhao
Responsible Party
Sponsor Investigator
Principal Investigator

Zeng Changhao

Research Director

People's Hospital of Zhengzhou University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Childhood Autism Rating Scale

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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