A comparative clinical study to evaluate the effect of virechana karma followed by kalyanaka kashaya and kalyanaka kashaya in the management of childhood autism
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.Reduction in the hyper activity
研究概览
简要总结
This study is a randomized, open lablled,parallel group, comparing the efficacy of virechana karma followed by oraladministration of kalyanaka Kashaya in dose of 10 ml or 20 ml according to age dailyand only oral administration of kalyanaka Kashaya 10 ml or 20 ml according toage daily in 30 children diagnosed with childhood Autism that will be conductedin single centre i.e SDM Institute of Ayurveda in India.The primary outcomemeasures will be reduction in hyperactivity, Improvement in the eye contact,Improvement inthe sensory issues,Improvement in the behavioral patterns, improvement insocial reciprocity and secondary measures like reduction in scores of MCHAT andISAA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 5.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children diagnosed with autism 2.5-16 years 3.Children of either gender 4.Children whose parents are willing to sign the informed assent.
排除标准
- •1.Children aged below 5 years 2.Children above 16 years of age.
- •3.Children with co- morbidities such as uncontrolled seizures, bi-polar disorder.
结局指标
主要结局
1.Reduction in the hyper activity
时间窗: 1 MONTH
4.Improvement in the behavioral patterns
时间窗: 1 MONTH
5.improvement in social reciprocity
时间窗: 1 MONTH
2.Improvement in the eye contact
时间窗: 1 MONTH
3.Improvement in the sensory issues
时间窗: 1 MONTH
次要结局
未报告次要终点