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Randomized Controlled Trial of Acupuncture Versus Sham Acupuncture in Autistic Spectrum Disorder

This study has been completed.
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00352248
First received: July 13, 2006
Last updated: NA
Last verified: July 1999
History: No changes posted
  Purpose

We aim to study the efficacy of Acupuncture versus sham acupuncture in children with ASD.


Condition Intervention Phase
Autistic Disorder
Autism
Procedure: Tongue Acupuncture (Procedure)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Acupuncture Versus Sham Acupuncture in Autistic Spectrum Disorder

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Griffiths Mental Developmental Scale (GMDS) was conducted before (at Week 0) and after (at Week 9) acupuncture.
  • Ritvo-Freeman Real Life Scale (RFRLS) was conducted before (at Week 0) and after (at Week 9) acupuncture.
  • Reynell Language Developmental Scale (RLDS) was conducted before (at Week 0) and after (at Week 9) acupuncture.
  • Symbolic Play Test (SPT) was conducted before (at Week 0) and after (at Week 9) acupuncture.
  • Functional Independence Measure for children (WeeFIM) was conducted before (at Week 0) and after (at Week 9) acupuncture.

Estimated Enrollment: 50
Detailed Description:

In Traditional Chinese Medicine (TCM) philosophy, the approach to Autistic Spectrum Disorder (ASD) is a holistic one. The objective is to study the efficacy of a short intensive course of Acupuncture versus sham acupuncture in improving the overall functional status of children with autism. A single-blind randomized control trial was conducted in 50 children. These children were randomly assigned to Treatment group with Tongue Acupuncture (40 sessions over 8 weeks) or Control group (Sham Tongue Acupuncture to non-acupoints in the tongue).

  Eligibility

Ages Eligible for Study:   3 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with diagnosis of autism made according to the criteria of the 4th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and Autism Diagnostic Interview-Revised and with a score for Childhood Autism Rating Scale (CARS) greater than 30.

Exclusion Criteria:

  • Children with associated neurological disorders and epilepsy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352248

Locations
Hong Kong
Duchess of Kent of Children Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Wong Virginia The University of Hong Kong
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00352248     History of Changes
Other Study ID Numbers: 9608944339555027
Study First Received: July 13, 2006
Last Updated: July 13, 2006
Health Authority: HKSAR: Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster

Keywords provided by The University of Hong Kong:
Alternative Medicine (AM)
Traditional Chinese Medicine
Tongue Acupuncture
Autistic Spectrum Disorder
Autism
Children

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Disease
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014