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

NCT ID: NCT06998459

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-28
• Study Completion Date: 2025-04-28

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.

Conditions

Evaluation of Bian Stone Therapy for Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bian-Stone therapy

Once a week, each session lasting 30 minutes, for a duration of six months.

Group Type: EXPERIMENTAL

Bian-Stone therapy

Intervention Type: OTHER

Once a week, each session lasting 30 minutes, for a duration of six months.

control group

Maintain the original treatment approach

Group Type: PLACEBO_COMPARATOR

Maintain the original treatment approach

Intervention Type: OTHER

Maintain the original treatment approach

Interventions

Bian-Stone therapy

Once a week, each session lasting 30 minutes, for a duration of six months.

Intervention Type: OTHER

Maintain the original treatment approach

Maintain the original treatment approach

Intervention Type: OTHER

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.

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.

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taichung Tzu Chi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shu-Yu Yang

Director of the Department of Pediatrics, Division of Traditional Chinese Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shu-Yu Yang

Role: PRINCIPAL_INVESTIGATOR

Taichung Tzu Chi Hospital

Locations

Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

REC 111-13

Identifier Type: -

Identifier Source: org_study_id