- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00352248
Randomized Controlled Trial of Acupuncture Versus Sham Acupuncture in Autistic Spectrum Disorder
July 13, 2006 updated by: The University of Hong Kong
We aim to study the efficacy of Acupuncture versus sham acupuncture in children with ASD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment
50
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, Hong Kong
- Duchess of Kent of Children Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 11 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Griffiths Mental Developmental Scale (GMDS) was conducted before (at Week 0) and after (at Week 9) acupuncture.
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Ritvo-Freeman Real Life Scale (RFRLS) was conducted before (at Week 0) and after (at Week 9) acupuncture.
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Reynell Language Developmental Scale (RLDS) was conducted before (at Week 0) and after (at Week 9) acupuncture.
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Symbolic Play Test (SPT) was conducted before (at Week 0) and after (at Week 9) acupuncture.
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Functional Independence Measure for children (WeeFIM) was conducted before (at Week 0) and after (at Week 9) acupuncture.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wong Virginia, The University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
July 13, 2006
First Submitted That Met QC Criteria
July 13, 2006
First Posted (Estimate)
July 14, 2006
Study Record Updates
Last Update Posted (Estimate)
July 14, 2006
Last Update Submitted That Met QC Criteria
July 13, 2006
Last Verified
July 1, 1999
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9608944339555027
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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