AutismPhase 3NCT00352352
Use of Acupuncture In Children With Autistic Spectrum Disorder
A Phase 3 study testing Tongue Acupuncture (Procedure) in people with Autism and Autistic Disorder, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a study of the efficacy of acupuncture in children with autism. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Autism, Autistic Disorder
- What is being tested?
- Tongue Acupuncture (Procedure)
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The diagnosis of ASD or autism was 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 (ADI-R).
- The diagnosis of autism was made if it satisfied a score greater than 30 in the Childhood Autism Rating Scale (CARS).
Who cannot join
- Children with associated neurological disorders such as Tuberous Sclerosis, Fragile X Syndrome and epilepsy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Trial of Using Acupuncture In Children With Autistic Spectrum Disorder
This is a study of the efficacy of acupuncture in children with autism.
Read the detailed description
Autism Spectrum Disorder (ASD) or autism is a neurodevelopmental disorder with unknown etiology. ASD consisted of 3 core features: 1) disorder of language or communication; 2) disorder of social interaction; and 3) obsessive and stereotypic behavior.
Acupuncture had been practiced in China for over two millennia. In Traditional Chinese Acupuncture, nearly 400 acupoints on the body surface are interrelated to various functions. The approach in TCM, in sharp contrast to western medical concept, was a "holistic" approach with a philosophical background of balancing the "Yin-and-Yang". The main objective of TCM was to improve health of body and mind by deblocking the flow of "Qi" in the body. The pathophysiological basis of TCM aimed to improve "energy" or "body-flow" or "Qi" ["de-qui" in Chinese]. The effect of acupuncture was had been proven in animal and human studies to be due to direct neural stimulation, changes in neurotransmitters such as endorphin, immunological markers or endocrinological signals. Thus, acupuncture is especially effective in chronic disorders, especially neurological ones.
As there is no TCM concept of mental retardation or autism, we propose that ASD is part of the spectrum of the TCM concept of the "Four Delayed Syndrome" in children with "delay in motor skills, speech, hair and teeth eruption" according to TCM concept. Thus, we approach ASD according to TCM concept as part of the lower intelligence due to imbalance of "Heart meridian and Kidney meridian" (i.e. yin-yang imbalance) resulting in communication problem and "Liver meridian" (yin-yang imbalance) leading to behavioral problems.
Our objective is to use a different approach in looking at ASD and to assess the efficacy of TCM model in improving the functional status of these children. Specific acupoints corresponding to various organs and meridians were used for ASD. The organ and meridian concept in TCM model has been as a fundamental basis to improve the behavior, cognition and communicative ability in children with ASD.
- Conditions
- Autism, Autistic Disorder
- Being tested
- Tongue Acupuncture (Procedure)
- Keywords
- Traditional Chinese Medicine (TCM), Alternative Medicine (AM), Tongue Acupuncture (TAC), Autism Spectrum Disorder (ASD), Autism, Children
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongue Acupuncture (Procedure)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Ritvo-Freeman Real Life Scale (RFRLS) was conducted on both groups before (Week 0) and after (Week 8) acupuncture.
Functional Independence Measure for children (WeeFIM) consists of 18 questions concerning on the Functional Independence Measure for children, which was conducted on both groups before (Week 0) and after (Week 8) acupuncture.
Parental Stress Index (PSI) consists of child domain, parent domain and a total domain, which was conducted on both groups before (Week 0) and after (Week 8) acupuncture.
Clinical Global Impression Scale (CGIS) is a measure in a Likert scale of 0 - 7, which was conducted on both groups before (Week 0) and after (Week 8) acupuncture.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Wong Virginia, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352352
- Sponsor's protocol ID
- 3469296479554546
- Status last verified
- Jul 1999
- First submitted
- 13 Jul 2006
- Last updated
- 14 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Using Acupuncture In Children With Autistic Spectrum Disorder
- ClinicalTrials.gov ID
- NCT00352352
- Acronym / sponsor ID
- 3469296479554546
- Conditions
- Autism, Autistic Disorder
- Keywords
- Traditional Chinese Medicine (TCM), Alternative Medicine (AM), Tongue Acupuncture (TAC), Autism Spectrum Disorder (ASD), Autism, Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- First posted
- 14 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of the efficacy of acupuncture in children with autism.
Detailed description
Autism Spectrum Disorder (ASD) or autism is a neurodevelopmental disorder with unknown etiology. ASD consisted of 3 core features: 1) disorder of language or communication; 2) disorder of social interaction; and 3) obsessive and stereotypic behavior.
Acupuncture had been practiced in China for over two millennia. In Traditional Chinese Acupuncture, nearly 400 acupoints on the body surface are interrelated to various functions. The approach in TCM, in sharp contrast to western medical concept, was a "holistic" approach with a philosophical background of balancing the "Yin-and-Yang". The main objective of TCM was to improve health of body and mind by deblocking the flow of "Qi" in the body. The pathophysiological basis of TCM aimed to improve "energy" or "body-flow" or "Qi" ["de-qui" in Chinese]. The effect of acupuncture was had been proven in animal and human studies to be due to direct neural stimulation, changes in neurotransmitters such as endorphin, immunological markers or endocrinological signals. Thus, acupuncture is especially effective in chronic disorders, especially neurological ones.
As there is no TCM concept of mental retardation or autism, we propose that ASD is part of the spectrum of the TCM concept of the "Four Delayed Syndrome" in children with "delay in motor skills, speech, hair and teeth eruption" according to TCM concept. Thus, we approach ASD according to TCM concept as part of the lower intelligence due to imbalance of "Heart meridian and Kidney meridian" (i.e. yin-yang imbalance) resulting in communication problem and "Liver meridian" (yin-yang imbalance) leading to behavioral problems.
Our objective is to use a different approach in looking at ASD and to assess the efficacy of TCM model in improving the functional status of these children. Specific acupoints corresponding to various organs and meridians were used for ASD. The organ and meridian concept in TCM model has been as a fundamental basis to improve the behavior, cognition and communicative ability in children with ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- The diagnosis of ASD or autism was 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 (ADI-R).
- The diagnosis of autism was made if it satisfied a score greater than 30 in the Childhood Autism Rating Scale (CARS).
Key exclusion criteria (1 listed)
- Children with associated neurological disorders such as Tuberous Sclerosis, Fragile X Syndrome and epilepsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tongue Acupuncture (Procedure) | Procedure or surgery | – |
Primary outcome
Ritvo-Freeman Real Life Scale (RFRLS) was conducted on both groups before (Week 0) and after (Week 8) acupuncture.
Functional Independence Measure for children (WeeFIM) consists of 18 questions concerning on the Functional Independence Measure for children, which was conducted on both groups before (Week 0) and after (Week 8) acupuncture.
Parental Stress Index (PSI) consists of child domain, parent domain and a total domain, which was conducted on both groups before (Week 0) and after (Week 8) acupuncture.
Clinical Global Impression Scale (CGIS) is a measure in a Likert scale of 0 - 7, which was conducted on both groups before (Week 0) and after (Week 8) acupuncture.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wong Virginia principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tongue Acupuncture (Procedure) in people with Autism and Autistic Disorder, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ritvo-Freeman Real Life Scale (RFRLS) was conducted on both groups before (Week 0) and after (Week 8) acupuncture.. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2006.