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Evaluation of the Effectiveness of Bian-Stone Therapy in Children With Autism Spectrum Disorder

T

Taichung Tzu Chi Hospital

Status

Completed

Conditions

Evaluation of Bian Stone Therapy for Autism Spectrum Disorder

Treatments

Other: Maintain the original treatment approach
Other: Bian-Stone therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06998459
REC 111-13

Details and patient eligibility

About

Autism spectrum disorder (ASD) is a pervasive developmental disorder of brain abnormalities. It presents with difficulties of communication and social interaction, and restrictive interests and restrictive behaviors. The CDC suggested that the popularity of ASD people is 1.5% in the US, and the male to female ratio is 4.5 to 1. In Taiwan, the popularity is around 1%, with the number increasing in recent years.

The exact etiology of ASD has remained unknown. Currently, the treatments include behavioral therapies, medication and alternative therapies. However, there is no specific way to cure the core symptoms of ASD. This study plans to apply behavioral therapies and traditional Chinese medical Bian-stone therapies on ASD children and compare the results between ASD children with only behavioral therapies. We will record theAutism Behavior Checklist-Taiwan Version, Development Screening Chart for Children Aged 0-6 Years, and Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) before and after the treatments, and meanwhile using the Ryodoraku Measurement (良導絡) to measure the meridian energy. This study aims to evaluate the effectiveness of traditional Chinese medical Bian-stone therapies in ASD children. In addition, we hope to investigate the relationship between ASD symptoms and twelve meridians and assess the patterns in Chinese medicine. Hopefully this study will help strengthen the clinical evidence in TCM treatments for ASD children and improve the efficacy of this disease.

Enrollment

22 patients

Sex

All

Ages

18 months to 6 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 1.Diagnosed with Autism Spectrum Disorder (ASD) based on DSM-5 diagnostic criteria, and additionally screened using the T-STAT assessment tool, with severity categorized as mild or moderate.

    2.Patients aged between 1.5 and under 6 years, regardless of gender. 3.A Full-Scale IQ of 70 or above as measured by the Wechsler Intelligence Scale for Children (WISC).

    4.No prior experience with Bianshi therapy. 5.Consent obtained from the patient or their guardian to provide relevant clinical data for use in this study.

Exclusion criteria

  • 1.Individuals who do not meet the aforementioned inclusion criteria. 2.Severe hearing, visual, or motor impairments, or diagnoses of cerebral palsy or epilepsy.

    3.Presence of other comorbid conditions, such as Tuberous Sclerosis, Fragile X Syndrome, Timothy Syndrome, male Rett Syndrome (with MECP2 gene mutation), and other chromosomal abnormalities (e.g., Angelman syndrome, Prader-Willi syndrome, Phelan-McDermid syndrome, and other related syndromes).

    4.Use of dietary supplements or health products.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

22 participants in 2 patient groups, including a placebo group

Bian-Stone therapy
Experimental group
Description:
Once a week, each session lasting 30 minutes, for a duration of six months.
Treatment:
Other: Bian-Stone therapy
control group
Placebo Comparator group
Description:
Maintain the original treatment approach
Treatment:
Other: Maintain the original treatment approach

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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