NCT00352248

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2006

Completed
Last Updated

July 14, 2006

Status Verified

July 1, 1999

First QC Date

July 13, 2006

Last Update Submit

July 13, 2006

Conditions

Autistic DisorderAutism

Keywords

Alternative Medicine (AM)Traditional Chinese MedicineTongue AcupunctureAutistic Spectrum DisorderAutismChildren

Outcome Measures

Primary Outcomes (5)

  • 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.

Interventions

Tongue Acupuncture (Procedure)PROCEDURE

Eligibility Criteria

Age3 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Children with associated neurological disorders and epilepsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duchess of Kent of Children Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Wong Virginia

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 13, 2006

First Posted

July 14, 2006

Last Updated

July 14, 2006

Record last verified: 1999-07

Locations

HK(1)