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

NCT07054697 | Completed Phase 4 DMC

• 1 other identifier: 20172024
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder (ASD)

Keywords

Homoeopathy; Autism Spectrum Disorder; Randomized Controlled Trial

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

Drug: Homoeopathic medicines; Behavioral: THERAPY

CONTROL GROUP

PLACEBO COMPARATOR

SACCHARUM LACTIS

Drug: Placebo; Behavioral: THERAPY

Interventions

Homoeopathic medicines DRUG

Also known as: 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

HOMOEOPATHIC GROUP

Placebo DRUG

Also known as: SACCHARUM LACTIS

CONTROL GROUP

THERAPY BEHAVIORAL

SPEECH THERAPY / OCCUPATIONAL THERAPY

CONTROL GROUP; HOMOEOPATHIC GROUP

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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. \[eg. a brain injury; fragile X syndrome or other syndromes resulting from known genetic defects or inherited metabolic diseases; other diagnosed conditions involving impairments in social and communication abilities, such as intellectual disability without ASD, schizophrenia, language disorders and social communication disorder\]
• Children with irregular follow ups.
• Children with poor medical compliance.

Sponsors & Collaborators

• Aditi Chadha: lead

Study Sites (1)

Holistic Homoeopathic Clinic and Research Center

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

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Homeopathy; Smallpox Vaccine; Causticum; Tuberculin; Datura stramonium lectin; Calcium Carbonate; Therapeutics

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Antigens, Bacterial; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors; Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

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: SPONSOR INVESTIGATOR
• PI Title: DOCTOR

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: January 1, 2017
• Primary Completion: December 31, 2024
• Study Completion: January 15, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-06

Locations

IN (1)