Autism Spectrum DisorderPhase 2NCT02363673
The Effect of Individualised Homoeopathic Treatment of Autism Spectrum Disorder in Children
A Phase 2 study testing Individualised homoeopathic remedy in aqua distilla in people with Autism Spectrum Disorder, run by University of Johannesburg at 1 site in South Africa.
Trial summary
The aim of this study is to determine the effect of individualised homoeopathic treatment of children with Autism Spectrum Disorder (ASD).This study is of descriptive case study design, with a structured interview and quantitative measurement components taking place over 12 weeks, with a consultation every 4 weeks. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Individualised homoeopathic remedy in aqua distilla
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Africa
- Study dates
- Feb 2015to Jul 2015
- Phase
- Phase 2
- 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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children aged of 3 to 6 years;
- diagnosed with ASD by a physician, psychologist, psychiatrist or neurologist;
- are on no medication or are on medication for ASD and its comorbid conditions for more than 2 months;
- are able to have their guardian present for all interviews, and
- have mild-to-moderate symptoms ASD as measured using the CARS
Who cannot join
- a history of or contract organic brain damage, meningitis, epilepsy or encephalitis;
- are on conventional medication such as Fluoxetine, Methylphenidate, Atomoxetine or Risperidal for less than 2 months or make use of any new medication for ASD or its comorbid conditions for the duration of the study, or
- currently be taking any herbal or homoeopathic medications.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
University of Johannesburg Doornfontein Campus
Johannesburg, Gauteng, 2094
About this study
The aim of this study is to determine the effect of individualised homoeopathic treatment of children with Autism Spectrum Disorder (ASD).This study is of descriptive case study design, with a structured interview and quantitative measurement components taking place over 12 weeks, with a consultation every 4 weeks. Children aged 3-6 years of age with ASD are invited to participate and their parent/guardian is required to be present during each consultation. Each consultation will consist of a homoeopathic case taking, conduction of the Childhood Autism Rating Scale (CARS) and Autism Treatment Evaluation Checklist (ATEC) measures and a brief physical exam. After each consultation, the participant will receive an individualised homoeopathic remedy, according to their individual symptoms and characteristics, to take for the subsequent 4 weeks. This remedy will be determined using the Mercurius® repertory software.
Read the detailed description
The aim of this study is to determine the effect of individualised homoeopathic treatment of children with Autism Spectrum Disorder (ASD). A minimum of 10 participants between the ages of 3 to 6 years, both male and female, will be recruited. This study is of a descriptive case study design, with a structured interview and quantitative measurement components. The data collection will take place over 12 weeks at both the University of Johannesburg's Health Training Centre and the schools for Autistic children within Gauteng.
A parent/guardian must be present for all consultations to aid data collection. Week 0 will consist of an explanation of the study, the Participant Information and Assent Form and the Parent/Guardian Information Form . The Consent Form will be signed by the parent or guardian if they wish their child to participate in the study. The child will also be informed on the details of the study and have to consent to their participation.
The participant will be screened using screening checklist, which includes the completion of the CARS by the researcher and guardian, to determine their eligibility to take part in the research study. If they are eligible to take part in the study, the researcher will conduct a case taking, the ATEC and a relevant physical examination (including vital signs). This information will serve as a baseline for each participant in the study along with the previous information attained from the CARS used in the participant's screening.
The first interview will consist of a structured interview of approximately 90 minutes duration with the parent/guardian, where after the following structured interviews will take 60 minutes, wherein the participant will be free to move around and interact with their environment as naturally as possible.
The researcher will then establish the participant's individualised homoeopathic remedy according to the principles of classical homoeopathy by using the Complete Repertory 2014 provided in Mercurius® repertory software.The selected remedy will be provided to the participant within 24 hours with instruction on how to take it.
The participant will be consulted with their parent/guardian 3 more times, at weeks 4, 8 and 12, where on each occasion they will have their case taken, the CARS and the ATEC conducted as well as a relevant physical examination. At the interviews on week 4 and 8, each case will be re-evaluated and the appropriate individualised homoeopathic remedy dispensed. Each participant will receive their individualised homoeopathic remedy in aqua distilla drops to be put into the participant's mouth, which will be prescribed with the most suitable repetition and potency for the participant, according to laws of homoeopathy that govern individualised homoeopathic prescribing. The case taking will assist in determining the potency and frequency of the remedy given. No remedy will be dispensed at week 12.
Data will be analysed by Statkon using non-parametric tests including the Friedman and the Wilcoxin post-hoc analyses. A positive outcome of this study will contribute to the accessibility of a complementary treatment for ASD as well as denote the requirement for further research studies on the subject. The outcome of this study may add to the body of knowledge of individualised homoeopathic treatment on ASD.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Individualised homoeopathic remedy in aqua distilla
- Keywords
- Autism Spectrum Disorder, Children, Homoeopathy
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualised homoeopathic remedy in aqua distillaOther
Each participant is to receive an individualised homoeopathic remedy according to their symptoms and characteristic manifestations of their disorder.
| Study group | Role | What they receive |
|---|---|---|
| Individualised Homoeopathic Remedy | Experimental | Each participant is to receive an individualised homoeopathic remedy in aqua distilla according to their symptoms and characteristic manifestations of their disorder. Although different individualised remedies may be dispensed, each remedy will be homoeopathic. Remedies will be dispensed in aqua distilla. Each individualised homoeopathic remedy will have an individualised dosage, frequency and duration based on the laws of individualised homoeopathic prescribing. Receives: Other: Individualised homoeopathic remedy in aqua distilla |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childhood Autism Rating Scale
The Childhood Autism Rating Scale will be conducted at weeks 0, 4, 8 and 12.
Measured: Every 4 weeks for 12 weeks
Secondary outcomes (2)
Autism Treatment Evaluation Checklist
The Autism Treatment Evaluation Checklist will be conducted at weeks 0, 4, 8 and 12.
Measured: Every 4 weeks for 12 weeks
Case notes
Qualitative data collection will be collect by means of case notes which will be taken at weeks 0, 4, 8 and 12.
Measured: Every 4 weeks for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Johannesburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr J. Pellow, University of Johannesburg
- Investigators
- N Gower, MTechHom, Study director, Senior Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363673
- Sponsor's protocol ID
- CGoodwin201006636
- Other IDs
- REC-01-128-2014
- Status last verified
- May 2016
- First submitted
- 9 Feb 2015
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Individualised Homoeopathic Treatment of Autism Spectrum Disorder in Children
- ClinicalTrials.gov ID
- NCT02363673
- Acronym / sponsor ID
- CGoodwin201006636
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Children, Homoeopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of JohannesburgUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 16 Feb 2015 (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.
The aim of this study is to determine the effect of individualised homoeopathic treatment of children with Autism Spectrum Disorder (ASD).This study is of descriptive case study design, with a structured interview and quantitative measurement components taking place over 12 weeks, with a consultation every 4 weeks. Children aged 3-6 years of age with ASD are invited to participate and their parent/guardian is required to be present during each consultation. Each consultation will consist of a homoeopathic case taking, conduction of the Childhood Autism Rating Scale (CARS) and Autism Treatment Evaluation Checklist (ATEC) measures and a brief physical exam. After each consultation, the participant will receive an individualised homoeopathic remedy, according to their individual symptoms and characteristics, to take for the subsequent 4 weeks. This remedy will be determined using the Mercurius® repertory software.
Detailed description
The aim of this study is to determine the effect of individualised homoeopathic treatment of children with Autism Spectrum Disorder (ASD). A minimum of 10 participants between the ages of 3 to 6 years, both male and female, will be recruited. This study is of a descriptive case study design, with a structured interview and quantitative measurement components. The data collection will take place over 12 weeks at both the University of Johannesburg's Health Training Centre and the schools for Autistic children within Gauteng.
A parent/guardian must be present for all consultations to aid data collection. Week 0 will consist of an explanation of the study, the Participant Information and Assent Form and the Parent/Guardian Information Form . The Consent Form will be signed by the parent or guardian if they wish their child to participate in the study. The child will also be informed on the details of the study and have to consent to their participation.
The participant will be screened using screening checklist, which includes the completion of the CARS by the researcher and guardian, to determine their eligibility to take part in the research study. If they are eligible to take part in the study, the researcher will conduct a case taking, the ATEC and a relevant physical examination (including vital signs). This information will serve as a baseline for each participant in the study along with the previous information attained from the CARS used in the participant's screening.
The first interview will consist of a structured interview of approximately 90 minutes duration with the parent/guardian, where after the following structured interviews will take 60 minutes, wherein the participant will be free to move around and interact with their environment as naturally as possible.
The researcher will then establish the participant's individualised homoeopathic remedy according to the principles of classical homoeopathy by using the Complete Repertory 2014 provided in Mercurius® repertory software.The selected remedy will be provided to the participant within 24 hours with instruction on how to take it.
The participant will be consulted with their parent/guardian 3 more times, at weeks 4, 8 and 12, where on each occasion they will have their case taken, the CARS and the ATEC conducted as well as a relevant physical examination. At the interviews on week 4 and 8, each case will be re-evaluated and the appropriate individualised homoeopathic remedy dispensed. Each participant will receive their individualised homoeopathic remedy in aqua distilla drops to be put into the participant's mouth, which will be prescribed with the most suitable repetition and potency for the participant, according to laws of homoeopathy that govern individualised homoeopathic prescribing. The case taking will assist in determining the potency and frequency of the remedy given. No remedy will be dispensed at week 12.
Data will be analysed by Statkon using non-parametric tests including the Friedman and the Wilcoxin post-hoc analyses. A positive outcome of this study will contribute to the accessibility of a complementary treatment for ASD as well as denote the requirement for further research studies on the subject. The outcome of this study may add to the body of knowledge of individualised homoeopathic treatment on ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individualised Homoeopathic Remedy | Experimental | Other: Individualised homoeopathic remedy in aqua distillaEach participant is to receive an individualised homoeopathic remedy in aqua distilla according to their symptoms and characteristic manifestations of their disorder. Although different individualised remedies may be dispensed, each remedy will be homoeopathic. Remedies will be dispensed in aqua distilla. Each individualised homoeopathic remedy will have an individualised dosage, frequency and duration based on the laws of individualised homoeopathic prescribing. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- children aged of 3 to 6 years;
- diagnosed with ASD by a physician, psychologist, psychiatrist or neurologist;
- are on no medication or are on medication for ASD and its comorbid conditions for more than 2 months;
- are able to have their guardian present for all interviews, and
- have mild-to-moderate symptoms ASD as measured using the CARS
Key exclusion criteria (3 listed)
- a history of or contract organic brain damage, meningitis, epilepsy or encephalitis;
- are on conventional medication such as Fluoxetine, Methylphenidate, Atomoxetine or Risperidal for less than 2 months or make use of any new medication for ASD or its comorbid conditions for the duration of the study, or
- currently be taking any herbal or homoeopathic medications.
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 |
|---|---|---|
| Individualised homoeopathic remedy in aqua distillaEach participant is to receive an individualised homoeopathic remedy according to their symptoms and characteristic manifestations of their disorder. | Other | Individualised Homoeopathic Remedy |
Primary outcome
Childhood Autism Rating Scale
Time frame: Every 4 weeks for 12 weeks
The Childhood Autism Rating Scale will be conducted at weeks 0, 4, 8 and 12.
2 secondary outcomes
Autism Treatment Evaluation Checklist
Time frame: Every 4 weeks for 12 weeks
Case notes
Time frame: Every 4 weeks for 12 weeks
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 19 May 2016.
- Individual participant dataSharing planned: No
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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.
N Gower, MTechHom study director
Senior Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Individualised homoeopathic remedy in aqua distilla in people with Autism Spectrum Disorder, run by University of Johannesburg at 1 site in South Africa.
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 5 inclusion and 3 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 19 May 2016. 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 South Africa. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Childhood Autism Rating Scale (time frame: Every 4 weeks for 12 weeks). 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 19 May 2016.