Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT07161804
Status:
COMPLETED
Last Update Posted:
2025-11-18
First Post:
2025-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot RCT Using Homeopathic Medicines in ASD
Sponsor:
Holistic Homoeopathic Clinic and Research Center
Organization:
Study Overview
Official Title:
A Single-blind Randomized Placebo Controlled Pilot Study With Individualized Homeopathic Treatment in the Children With Autism Spectrum Disorder (ASD)
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Pilot-RCT-ASD
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.
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.
Detailed Description:
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: