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Pilot-RCT With Individualized Homeopathic Treatment in the Children With Autism Spectrum Disorder

A Single-blind Randomized Placebo Controlled Pilot Study With Individualized Homeopathic Treatment in the Children With Autism Spectrum Disorder

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07054697
Acronym
Pilot-RCT ASD
Enrollment
54
Registered
2025-07-08
Start date
2017-01-01
Completion date
2025-01-15
Last updated
2025-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder (ASD)

Keywords

Homoeopathy, Autism Spectrum Disorder, Randomized Controlled Trial

Brief summary

This study looked at whether homeopathic treatment could help children with Autism Spectrum Disorder (ASD) when used alongside regular therapies like speech and occupational therapy. Over seven years, children between the ages of 2 and 12 were divided into two groups (through computer generated list). One group received individualized homeopathic medicines, and the other received a look-alike placebo (with no active ingredients). Meanwhile, both the groups continued with their regular therapies. Researchers used various tools and parent questionnaires to track the children's progress in areas like communication, behavior, social skills, daily functioning, toilet training and sensory skills. They found that the children who received homeopathic treatment showed more improvement in these areas compared to those who just received only speech / occupational therapies.

Interventions

DRUGPlacebo
BEHAVIORALTHERAPY

SPEECH THERAPY / OCCUPATIONAL THERAPY

Sponsors

Aditi Chadha
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* A confirmed diagnosis of Autism Spectrum Disorder (ABC score ≥ 67) * Age range of 2 to 12 years

Exclusion criteria

* Children with other significant comorbid psychiatric conditions that could confound the results. \[eg. a brain injury; fragile X syndrome or other syndromes resulting from known genetic defects or inherited metabolic diseases; other diagnosed conditions involving impairments in social and communication abilities, such as intellectual disability without ASD, schizophrenia, language disorders and social communication disorder\] * Children with irregular follow ups. * Children with poor medical compliance.

Design outcomes

Primary

MeasureTime frameDescription
Childhood Autism Rating Scale (CARS)BASELINE, YEARLY (0-7 YEARS)To measure various behavioral dimensions and adaptive functioning
Autism Treatment Evaluation Checklist (ATEC)BASELINE, YEARLY (0 - 7 YEARS)To assess the efficacy of the treatment among both the arms.

Secondary

MeasureTime frameDescription
Social Responsiveness Scale (SRS)BASELINE, YEARLY (0 - 7 YEARS)To measure social skills, communication abilities.
Neurodevelopmental Parent Report for Outcome Monitoring (ND PROM)BASELINE, YEARLY (0 - 7 YEARS)To gather subjective reports on their children's behavior, social interactions, and overall well-being from the parents.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026