Effectiveness of Individualized Homoeopathic Medicines in LM Potencies in the management of children with Autism Spectrum Disorder
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Assessment of reduction in the severity of symptoms in children with Autism Spectrum Disorder after the administration of Individualized Homoeopathic Medicines in LM potencies is planned to be done every month using the Indian Scale for Assessment of Autism (ISAA).
研究概览
简要总结
This study is an open label, single arm, clinical interventional study to determine the effectiveness of Individualized Homoeopathic Medicines in LM potencies in the management of children with Autism Spectrum Disorder that will be conducted in OPD, IPD and Peripheral units of Department of Psychiatry at National Homoeopathy Research Institute in Mental Health, Kottayam. The primary outcome measures will be, the reduction in the severity of symptoms; assessed using the Indian Scale for Assessment of Autism (ISAA) every monthly. The secondary outcome will be, the changes in the challenging behavior; assessed every three months by using the Aberrant Behavior Checklist (ABC) scale. As the study with the aforementioned domains is one of its kind, it aims to make the efforts to offer possibilities for future research in the effectiveness of Individualized Homoeopathic Medicines in LM potency in management of children with Autism Spectrum Disorder in general and in the management of challenging behaviors in particular.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •Children in the age group of 3 to 17 years and both sexes.
- •Participants diagnosed with Autism Spectrum Disorder as per the DSM–V.
排除标准
- •Participants diagnosed with any organic disorders.
- •Participants with any other serious medical illness and multiple disabilities.
结局指标
主要结局
Assessment of reduction in the severity of symptoms in children with Autism Spectrum Disorder after the administration of Individualized Homoeopathic Medicines in LM potencies is planned to be done every month using the Indian Scale for Assessment of Autism (ISAA).
时间窗: Every month from baseline till the conclusion of the study (12th month)
次要结局
- The changes in the challenging behavior in children with Autism Spectrum Disorder after the administration of Individualized Homoeopathic Medicines in LM potencies will be assessed at baseline, at 3rd, 6th, 9th month and at the conclusion of the study by using the Aberrant Behavior Checklist (ABC) scale.(Baseline, at 3rd, 6th, 9th month and at the conclusion of the study (12th month))
研究者
Dr. Sourabh Balgonda Patil
National Homoeopathy Research Institute in Mental Health