Pilot RCT Using Homeopathic Medicines in ASD (Pilot-RCT-ASD)

Holistic Homoeopathic Clinic and Research Center

Status and phase: Completed; Phase 4

Conditions: Autism Spectrum Disorder (ASD)

Treatments: Drug: Placebo; Behavioral: Therapy; Drug: Homoeopathic medicines

Study type: Interventional

Funder types: Other

Identifiers

NCT07161804

201724112024

Details and patient eligibility

About

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.

Full 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).

Enrollment: 54 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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, global developmental delay, language disorders and social communication disorder]
• Children with irregular follow ups.
• Children with poor medical compliance.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups, including a placebo group

Homoeopathic Group

Experimental group

Description:

Individualized Homoeopathic Medicines

Treatment:

Drug: Homoeopathic medicines

Behavioral: Therapy

Control Group

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Behavioral: Therapy