A Single-blind Randomized Placebo Controlled Pilot Study With Individualized Homeopathic Treatment in the Children With Autism Spectrum Disorder (ASD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Childhood Autism Rating Scale (CARS)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A confirmed diagnosis of Autism Spectrum Disorder (ABC score ≥ 67)
- •Age range of 2 to 12 years
排除标准
- •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.
研究组 & 干预措施
Homoeopathic Group
Individualized Homoeopathic Medicines
干预措施: Homoeopathic medicines (Drug)
Homoeopathic Group
Individualized Homoeopathic Medicines
干预措施: Therapy (Behavioral)
Control Group
Placebo
干预措施: Therapy (Behavioral)
Control Group
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Childhood Autism Rating Scale (CARS)
时间窗: Baseline, Yearly (0 - 7 years)
To measure various behavioral dimensions and adaptive functioning
Autism Treatment Evaluation Checklist (ATEC)
时间窗: Baseline, Yearly (0 - 7 years)
To assess the efficacy of the treatment among both the arms.
次要结局
- Social Responsiveness Scale (SRS)(Baseline, Yearly (0 - 7 years))
- Neurodevelopmental Parent Report for Outcome Monitoring (ND PROM)(Baseline, Yearly (0 - 7 years))
研究者
Gyandas Wadhwani
Principal Investigator
Holistic Homoeopathic Clinic and Research Center