Skip to content

A Pragmatic Randomized Controlled Trial on TCM Appropriate Techniques for Intervening in ASD

Development, Evaluation, and Demonstration of Traditional Chinese Medicine Appropriate Techniques for the Intervention of Autism Spectrum Disorder in Belt and Road Countries

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002393
Enrollment
Unknown
Registered
2025-12-06
Start date
2025-12-10
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder, ASD

Interventions

Treatment Group A:Acupuncture + Tuina + Rehabilitation
Treatment Group B:Acupuncture + Rehabilitation

Sponsors

Xi'an TCM Hospital of Encephalopathy
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for Autism Spectrum Disorder as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). 2. Children aged 2-12 years, regardless of gender. 3. Possess an intelligence quotient (IQ) ranging from 40 to 69 (indicating moderate to mild intellectual disability) as assessed by the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV; for children aged 2 years 6 months to 6 years 11 months) or the Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV; for children aged 6 to 16 years). 4. Be a native Mandarin Chinese speaker. 5. Be capable of cooperating with the treatment procedures and assessment protocols. 6. Have a parent or legal guardian who has voluntarily provided written informed consent to participate in the study and is able to cooperate in completing the treatment course.

Exclusion criteria

Exclusion criteria: 1. Diagnosed with schizophrenia, epilepsy, Heller's syndrome, or Rett syndrome. 2. Presence of severe organic lesions, genetic metabolic disorders, or infectious diseases. 3. Currently taking psychotropic or sedative medications. 4. History of severe self-injury or suicidal behavior within the past year. 5. Severe visual, auditory, speech, or motor impairments that prevent cooperation with assessment or treatment. 6. Other systemic diseases requiring special management that may interfere with the treatment in this study. 7. Concurrent participation in other clinical studies.

Design outcomes

Primary

MeasureTime frame
Autism Treatment Evaluation Checklist, ATEC;

Secondary

MeasureTime frame
Childhood Autism Rating Scale - 2, CARS-2;Autism Behavior Checklist, ABC;Children's Sleep Habits Questionnaire, CSHQ;Bristol stool form scale, BSFS;Spontaneous Bowel Movements, SBMs;Electroencephalogram, EEG;

Countries

CHINA

Contacts

Public ContactNingxia Zhao

Xi'an TCM Hospital of Encephalopathy

18729228830@163.com8618729228830

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026