Evaluation of Bian Stone Therapy for Autism Spectrum DisorderNCT06998459
Evaluation of the Effectiveness of Bian-Stone Therapy in Children With Autism Spectrum Disorder
A study testing Bian-Stone therapy and Maintain the original treatment approach in people with Evaluation of Bian Stone Therapy for Autism Spectrum Disorder, run by Taichung Tzu Chi Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 6 years
- Conditions the study is for
- Evaluation of Bian Stone Therapy for Autism Spectrum Disorder
- What is being tested?
- Bian-Stone therapy and Maintain the original treatment approach
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Apr 2025to 28 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Taiwan1 site
Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Taichung, 427
About this study
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.
- Being tested
- Bian-Stone therapy, Maintain the original treatment approach
- Keywords
- Bian-Stone therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bian-Stone therapyOther
Once a week, each session lasting 30 minutes, for a duration of six months.
Maintain the original treatment approachOther
Maintain the original treatment approach
| Study group | Role | What they receive |
|---|---|---|
| Bian-Stone therapy | Experimental | Once a week, each session lasting 30 minutes, for a duration of six months. Receives: Other: Bian-Stone therapy |
| control group | Placebo comparator | Maintain the original treatment approach Receives: Other: Maintain the original treatment approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autism Behavior Checklist-Taiwan Version
This checklist includes 47 items across five categories: sensory, relating, body and object use, language, and social and self-help skills. The raw score is based on the number of questions answered "yes." This score is then compared with appropriate norms to determine the individual's position relative to the norms.
Pre-test, mid-test at 3 months, and post-test at 6 months. Development Screening Chart for Children Aged 0-6 Years This scale measures development across five categories: communication and language development, social and personality development, gross motor skills, fine motor skills, and perceptual and cognitive development. It includes 19 age groups, from birth to 72 months, and organizes developmental abilities in order.
Measured: Pre-test, mid-test at 3 months, and post-test at 6 months.
Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)
This tool assesses adaptive behavior across four domains: communication, daily living skills, socialization, and motor skills. It provides standard scores for each domain and an overall composite score, with lower scores indicating higher levels of impairment. Age-equivalent scores for each domain were calculated by averaging the subdomain scores, based on previous research methodologies.
Measured: Pre-test, mid-test at 3 months, and post-test at 6 months.
Development Screening Chart for Children Aged 0-6 Years
This scale measures development across five categories: communication and language development, social and personality development, gross motor skills, fine motor skills, and perceptual and cognitive development. It includes 19 age groups, from birth to 72 months, and organizes developmental abilities in order.
Measured: Pre-test, mid-test at 3 months, and post-test at 6 months.
Secondary outcomes (1)
Meridian Energy Analysis Device
This study used the MEAD Meridian Energy Analysis Device (ME-10), developed by Med-Pex, Taipei, Taiwan, and certified by the Department of Health (Medical Device No. 002062). Based on Dr. Yoshio Nakatani's Ryodoraku theory, the device measures Qi imbalances across 24 points on the 12 major meridians. Measured acupoints included LU9, PC7, HT7, SI4, SJ4, LI5, ST42, LR3, KI4, BL65, GB40, and SP3. Qi imbalance patterns in allergic rhinitis participants were analyzed by comparing mean meridian values. The upper/lower ratio, calculated by dividing the sum of upper meridian values by that of the lower, reflects mental health status.
Measured: Pre-test, mid-test at 3 months, and post-test at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start28 Apr 2025
- Primary completion28 Apr 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of Bian Stone Therapy for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Tzu Chi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-Yu Yang, Taichung Tzu Chi Hospital
- Investigators
- Shu-Yu Yang, Principal investigator, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998459
- Sponsor's protocol ID
- REC 111-13
- Status last verified
- May 2025
- First submitted
- 22 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Bian-Stone Therapy in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06998459
- Acronym / sponsor ID
- REC 111-13
- Keywords
- Bian-Stone therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Taichung Tzu Chi HospitalUniversity, hospital or other
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bian-Stone therapy | Experimental | Other: Bian-Stone therapyOnce a week, each session lasting 30 minutes, for a duration of six months. |
| control group | Placebo comparator | Other: Maintain the original treatment approachMaintain the original treatment approach |
Who may qualify
- Ages
- 18 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bian-Stone therapyOnce a week, each session lasting 30 minutes, for a duration of six months. | Other | Bian-Stone therapy |
| Maintain the original treatment approachMaintain the original treatment approach | Other | control group |
Primary outcome
Autism Behavior Checklist-Taiwan Version
Time frame: Pre-test, mid-test at 3 months, and post-test at 6 months.
This checklist includes 47 items across five categories: sensory, relating, body and object use, language, and social and self-help skills. The raw score is based on the number of questions answered "yes." This score is then compared with appropriate norms to determine the individual's position relative to the norms. Pre-test, mid-test at 3 months, and post-test at 6 months. Development Screening Chart for Children Aged 0-6 Years This scale measures development across five categories: communication and language development, social and personality development, gross motor skills, fine motor skills, and perceptual and cognitive development. It includes 19 age groups, from birth to 72 months, and organizes developmental abilities in order.
Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)
Time frame: Pre-test, mid-test at 3 months, and post-test at 6 months.
This tool assesses adaptive behavior across four domains: communication, daily living skills, socialization, and motor skills. It provides standard scores for each domain and an overall composite score, with lower scores indicating higher levels of impairment. Age-equivalent scores for each domain were calculated by averaging the subdomain scores, based on previous research methodologies.
Development Screening Chart for Children Aged 0-6 Years
Time frame: Pre-test, mid-test at 3 months, and post-test at 6 months.
This scale measures development across five categories: communication and language development, social and personality development, gross motor skills, fine motor skills, and perceptual and cognitive development. It includes 19 age groups, from birth to 72 months, and organizes developmental abilities in order.
1 secondary outcome
Meridian Energy Analysis Device
Time frame: Pre-test, mid-test at 3 months, and post-test at 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu-Yu Yang principal investigator
Taichung Tzu Chi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bian-Stone therapy and Maintain the original treatment approach in people with Evaluation of Bian Stone Therapy for Autism Spectrum Disorder, run by Taichung Tzu Chi Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autism Behavior Checklist-Taiwan Version (time frame: Pre-test, mid-test at 3 months, and post-test at 6 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.