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Stellate Ganglion Block in Children With Autistic Disorder: A Randomized Controlled Trial

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What is being tested

Routine therapy

+ Stellate ganglion block

+ Lidocaine hydrochloride

BehavioralProcedureDrug
Who is being recruted

Autism Spectrum Disorder+2

+ Autistic Disorder

+ Mental Disorders

From 4 Months to 8 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: March 2024
See protocol details

Summary

Principal SponsorCopka Sonpashan
Study ContactLavie Ce
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2024

Actual date on which the first participant was enrolled.

This clinical trial focuses on children diagnosed with Autistic Disorder, a condition that is becoming more common. The main goal is to find out if a procedure called a stellate ganglion block can help improve symptoms in these children. The study is significant because it explores a potential new treatment option that could enhance the quality of life for children with autism, addressing the growing need for effective interventions. In this study, participants are divided into two groups. Both groups receive the standard therapy for autism, but the experimental group also receives the stellate ganglion block. This procedure involves an injection near a cluster of nerves in the neck, which is thought to influence symptoms. To measure the effectiveness, researchers use the Childhood Autism Rating Scale to evaluate changes in symptoms before and after the treatment. This helps determine if the stellate ganglion block offers any additional benefits beyond routine therapy.

Official TitleStellate Ganglion Block in Children With Autistic Disorder: A Randomized Controlled Trial
NCT06319599
Principal SponsorCopka Sonpashan
Study ContactLavie Ce
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 4 Months to 8 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autism Spectrum DisorderAutistic DisorderMental DisordersChild Development Disorders, PervasiveNeurodevelopmental Disorders

Criteria

3 inclusion criteria required to participate
Diagnosed as Autistic Disorder.
Aged between 4 years old and 8 years old.
No contraindications to stellate ganglion block.
2 exclusion criteria prevent from participating
Other significant physical or neurodevelopmental disorders.
Other significant medical conditions

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
The study lasts 10d for each patient. During the treatment, All the participants are provided with the routine rehabilitation therapy. Based on the invention above, the patients in the experimental group were provided with stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g)

Group II

Placebo
The study lasts 10d for each patient. During the treatment, All the participants are provided with the routine rehabilitation therapy.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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