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Clinical Trials/NCT00352248
NCT00352248
Completed
Phase 3

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

The University of Hong Kong1 site in 1 country50 target enrollmentJuly 14, 2006

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Autistic Disorder
Sponsor
The University of Hong Kong
Enrollment
50
Locations
1
Primary Endpoint
Griffiths Mental Developmental Scale (GMDS) was conducted before (at Week 0) and after (at Week 9) acupuncture.
Status
Completed
Last Updated
19 years ago

Overview

Brief Summary

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

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).

Registry
clinicaltrials.gov
Start Date
July 14, 2006
End Date
TBD
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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