A Phase 4 interventional study of Homoeopathic medicines and Therapy in Autism Spectrum Disorder (ASD), sponsored by Holistic Homoeopathic Clinic and Research Center. Completed at 1 site in India. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by Holistic Homoeopathic Clinic and Research Center · Phase 4, Interventional, and Treatment
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.
Autism spectrum disorders (ASD) are lifetime neurodevelopmental disorders with challenges across functional domains. Despite availability of various treatment modalities and diagnostic tools, it's pathophysiology still remains poorly understood even through 8 decades of it's discovery. This pilot study compares psychometrics and parental reported outcome monitoring, behavioral and developmental outcomes, co-occurring breadth of concerns for children with ASD along with co-morbidities, with and without homeopathic treatment.
Methodology: Initial screening was done using Autism Behavior Checklist (ABC). Utilizing a randomized-controlled design and parental informed consent, this study compared children aged 3 to 12 years, divided into an experimental group receiving individualized homeopathic treatment alongside occupational/speech therapies (HG), and a control group receiving only latter (CG) .
The treatment group received homoeopathic medicines daily with frequency being once per day along with daily occupational / speech therapy sessions for 1 hour each. The control group received homoeopathic medicine look alike placebo daily with frequency being once per day along with daily occupational / speech therapy sessions for 1 hour each. Follow ups were done every 3 months and the data were combined and stored for each year separately for seven-years. The data was initially collected and then analyzed through standardized behavioral assessments [Childhood Autism Rating Scale, CARS] , speech-language assessments [Social Responsiveness Scale, SRS], parental-questionnaires for reporting emotional regulation, anxiety-related behaviors, co-morbidities [Neuro Developmental Parent Report for Outcome Monitoring, ND-PROM] and observational methods in both the groups. The treatment effectiveness was assessed using Autism Treatment Evaluation Checklist (ATEC).
1,726 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.
This study's enrollment of 54 is close to the median of 52 across 1,370 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →This is the only study on the registry with Holistic Homoeopathic Clinic and Research Center as lead sponsor.
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Exclusion Criteria:
Individualized Homoeopathic Medicines
Drug: Homoeopathic medicines · Behavioral: Therapy
Placebo
Behavioral: Therapy · Drug: Placebo
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Also known as: Medicines
Occupational Therapy / Speech Therapy
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Childhood Autism Rating Scale (CARS)
To measure various behavioral dimensions and adaptive functioning
Time frame: Baseline, Yearly (0 - 7 years)
Autism Treatment Evaluation Checklist (ATEC)
To assess the efficacy of the treatment among both the arms.
Time frame: Baseline, Yearly (0 - 7 years)
Social Responsiveness Scale (SRS)
To measure social skills, communication abilities.
Time frame: 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.
Time frame: Baseline, Yearly (0 - 7 years)
Plan to share: No — TO MAINTAIN CONFIDENTIALITY
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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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