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Completed

NCT Number: NCT07054697

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

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.

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Key information

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Holistic Homoeopathic Clinic and Research Center

New Delhi, National Capital Territory of Delhi, 110024, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Homoeopathic medicines

Drug

Other names: THUJA OFFICINALIS, VACCININUM, CAUSTICUM, ARGENTUM NITRICUM, TUBERCULINUM, STRAMONIUM, STAPHYSAGRIA, ARUM TRIPHYLLUM, BACILLINUM, CINA, CARCINOCIN, CUPRUM METALLICUM, AMBER GRISEA, CALCAREA CARBONICA, CROCUS SATIVUS, HEPAR SULPHUR, HYOSCYMUS, KALI BROMATUM, LAC VACCININUM, MEDORRHINUM, NATRUM PHOSPHORICUM

Placebo

Drug

Other names: SACCHARUM LACTIS

Therapy

Behavioral

SPEECH THERAPY / OCCUPATIONAL THERAPY

Primary outcomes

  1. Childhood Autism Rating Scale (CARS)

    Time frame: BASELINE, YEARLY (0-7 YEARS)

    To measure various behavioral dimensions and adaptive functioning

  2. Autism Treatment Evaluation Checklist (ATEC)

    Time frame: BASELINE, YEARLY (0 - 7 YEARS)

    To assess the efficacy of the treatment among both the arms.

Secondary outcomes

  1. Social Responsiveness Scale (SRS)

    Time frame: BASELINE, YEARLY (0 - 7 YEARS)

    To measure social skills, communication abilities.

  2. Neurodevelopmental Parent Report for Outcome Monitoring (ND PROM)

    Time frame: BASELINE, YEARLY (0 - 7 YEARS)

    To gather subjective reports on their children's behavior, social interactions, and overall well-being from the parents.

Sponsors and collaborators

Lead sponsor

Aditi Chadha

Other

Registry information

Official study title

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

Acronym: Pilot-RCT ASD

Important dates

Study start
2017
Primary completion
2024
Study completion
2025
First posted
Jul 8, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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