Clinical trial NCT06998459: Evaluation of the Effectiveness of Bian-Stone Therapy in Children With Autism Spectrum Disorder
Official title: Evaluation of the Effectiveness of Bian-Stone Therapy in Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaluation of Bian Stone Therapy for Autism Spectrum Disorder
Keywords: Bian-Stone therapy
Lead sponsor: Taichung Tzu Chi Hospital
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Autism Behavior Checklist-Taiwan Version
timeFrame: Pre-test, mid-test at 3 months, and post-test at 6 months.
measure: Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)
timeFrame: Pre-test, mid-test at 3 months, and post-test at 6 months.
measure: Development Screening Chart for Children Aged 0-6 Years
timeFrame: Pre-test, mid-test at 3 months, and post-test at 6 months.
Secondary outcomes:
measure: Meridian Energy Analysis Device
timeFrame: Pre-test, mid-test at 3 months, and post-test at 6 months.
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study officials:
affiliation: Taichung Tzu Chi Hospital
name: Shu-Yu Yang
role: PRINCIPAL_INVESTIGATOR
References: