Role of individualized homoeopathic medicine in the management of autism spectrum disorder 3 to 18 years a prospective single arm pre post clinical study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in the quantitative and overall score in severity of symptoms of autism spectrum disorder by the application of ISAA scale
研究概览
简要总结
This study is to assess the role of Homoeopathic Medicines in the treatment of Autism spectrum disorder
sample size 30
prospective single arm pre post clinical trial
15 months study
ISAA scale used for assessment
scores at baseline after 3 months and after 6 months will be used for final assessment
changes in the quantitative and overall score in severity of symptoms of Autism spectrum disorder by the application of ISAA scale
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 18.00 Year(s)(—)
- 性别
- All
入选标准
- •Participants of 3 to 18 years of age irrespective of their religion and gender Clinically diagnosed cases of autism spectrum disorder with or without comorbidities Participant fulfilling the criteria of ISSA scale with score between 70 to 153 70 mild autism more than 153 severe autism participants whose parents legally authorized guardian are willing to give consent for the study.
排除标准
- •Participants with severe systemic illness any immunocompromised condition severe psychiatric issues substance abuse and severe endocrine disorders Participants who are currently involved in other clinical trials or interventions that might conflict with or bias the outcomes of this study.
结局指标
主要结局
Changes in the quantitative and overall score in severity of symptoms of autism spectrum disorder by the application of ISAA scale
时间窗: 15 months study | 6 months enrollment | 6 months follow up | 3 months report writing and data analysis
次要结局
未报告次要终点
研究者
Dr Nidhika Ranganathan
bakson homoeopathic medical college and hospital
