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

A Single-blind Randomized Placebo Controlled Pilot Study 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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder (ASD)
• Intervention / Treatment: Drug: Placebo; Drug: Homoeopathic medicines; Behavioral: THERAPY

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110024
      • Holistic Homoeopathic Clinic and Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HOMOEOPATHIC GROUP	Drug: Homoeopathic medicines; 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; Behavioral: THERAPY; SPEECH THERAPY / OCCUPATIONAL THERAPY
Placebo Comparator: CONTROL GROUP; SACCHARUM LACTIS	Drug: Placebo; Other Names: SACCHARUM LACTIS; Behavioral: THERAPY; SPEECH THERAPY / OCCUPATIONAL THERAPY

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aditi Chadha

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): January 15, 2025

Study Registration Dates

• First Submitted: June 27, 2025
• First Submitted That Met QC Criteria: June 27, 2025
• First Posted (Estimated): July 8, 2025

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Autism Spectrum Disorder; Homoeopathy
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autism Spectrum Disorder; Autistic Disorder; Child Development Disorders, Pervasive; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antacids; Calcium Carbonate
• Other Study ID Numbers: 20172024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: TO MAINTAIN CONFIDENTIALITY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No