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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 30 May 2016
Main ID:  NCT02363673
Date of registration: 09/02/2015
Prospective Registration: No
Primary sponsor: University of Johannesburg
Public title: The Effect of Individualised Homoeopathic Treatment of Autism Spectrum Disorder in Children
Scientific title: The Effect of Individualised Homoeopathic Treatment of Autism Spectrum Disorder in Children
Date of first enrolment: February 2015
Target sample size: 10
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02363673
Study type:  Interventional
Study design:  Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
South Africa
Contacts
Name:     N Gower, MTechHom
Address: 
Telephone:
Email:
Affiliation:  Senior Lecturer
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.



Age minimum: 3 Years
Age maximum: 6 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Autism Spectrum Disorder
Intervention(s)
Other: Individualised homoeopathic remedy in aqua distilla
Primary Outcome(s)
Childhood Autism Rating Scale [Time Frame: Every 4 weeks for 12 weeks]
Secondary Outcome(s)
Case notes [Time Frame: Every 4 weeks for 12 weeks]
Autism Treatment Evaluation Checklist [Time Frame: Every 4 weeks for 12 weeks]
Secondary ID(s)
CGoodwin201006636
REC-01-128-2014
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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