NCT07161804

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 3 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 31, 2016

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

8 years

First QC Date

July 27, 2025

Last Update Submit

November 17, 2025

Conditions

Autism Spectrum Disorder (ASD)

Keywords

ASDRCTHOMEOPATHY

Outcome Measures

Primary Outcomes (2)

  • Childhood Autism Rating Scale (CARS)

    To measure various behavioral dimensions and adaptive functioning

    Baseline, Yearly (0 - 7 years)

  • Autism Treatment Evaluation Checklist (ATEC)

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

    Baseline, Yearly (0 - 7 years)

Secondary Outcomes (2)

  • Social Responsiveness Scale (SRS)

    Baseline, Yearly (0 - 7 years)

  • Neurodevelopmental Parent Report for Outcome Monitoring (ND PROM)

    Baseline, Yearly (0 - 7 years)

Study Arms (2)

Homoeopathic Group

EXPERIMENTAL

Individualized Homoeopathic Medicines

Drug: Homoeopathic medicinesBehavioral: Therapy

Control Group

PLACEBO COMPARATOR

Placebo

Behavioral: TherapyDrug: Placebo

Interventions

Homoeopathic medicinesDRUG

Thuja officinalis Vaccininum Causticum Argentum nitricum Tuberculinum Stramonium Staphysagria Arum triphyllum Bacillinum Cina Carcinocin Cuprum Metallicum Ambera grisea Calcarea carbonica Crocus sativus Hepar sulphur Hyoscymus Kali Bromatum Lac Vaccininum Medorrhinum Natrum phosphoricum Thyroidinum

Also known as: Medicines
Homoeopathic Group
TherapyBEHAVIORAL

Occupational Therapy / Speech Therapy

Control GroupHomoeopathic Group
PlaceboDRUG

Saccharum lactis

Control Group

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holistic Homoeopathic Clinic and Research Center

New Delhi, SOUTH DELHI, 110024, India

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

HomeopathyDosage FormsTherapeutics

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Complementary TherapiesPharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Officials

  • GYANDAS G WADHWANI, MD (HOM.)

    Holistic Homoeopathic Clinic and Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 27, 2025

First Posted

September 9, 2025

Study Start

December 31, 2016

Primary Completion

December 31, 2024

Study Completion

January 13, 2025

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

TO MAINTAIN CONFIDENTIALITY

Locations

IN(1)