The Effect of Individualised Homoeopathic Treatment of Autism Spectrum Disorder in Children

NCT02363673 | Completed Phase 2

• 2 other identifiers: CGoodwin201006636REC-01-128-2014
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Children; Homoeopathy

Outcome Measures

Primary Outcomes (1)

• Childhood Autism Rating Scale

  The Childhood Autism Rating Scale will be conducted at weeks 0, 4, 8 and 12.

  Every 4 weeks for 12 weeks

Secondary Outcomes (2)

• Autism Treatment Evaluation Checklist

  Every 4 weeks for 12 weeks

• Case notes

  Every 4 weeks for 12 weeks

Study Arms (1)

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.

Other: Individualised homoeopathic remedy in aqua distilla

Interventions

Individualised homoeopathic remedy in aqua distilla OTHER

Each participant is to receive an individualised homoeopathic remedy according to their symptoms and characteristic manifestations of their disorder.

Individualised Homoeopathic Remedy

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Johannesburg: lead

Study Sites (1)

University of Johannesburg Doornfontein Campus

Johannesburg, Gauteng, 2094, South Africa

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• N Gower, MTechHom

  Senior Lecturer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr J. Pellow

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 16, 2015
• Study Start: February 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 19, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)