Comparative exploratory study on Brihat Saraswat Churna with or without Brahmi Taila Pratimarsh Nasya in the management of Hyperactivity disorder in Children
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Brihat Saraswat Churna and Brahmi Taila Pratimarsh Nasya may be effective to ameliorate
研究概览
简要总结
Number of Patient- 100
Intervention Groups - Two group
Sample Size - 50 Children in each group
Type of Study- Open Labelled Drug- Group 1st Brihat Saraswat Churna with Brahmi Taila Pratimarsha nasya and Group 2nd Brihat Saraswat Churna
Dose- Brihat Saraswat Churna will be given in three divided doses as per Young Formula
While Brahmi Tail Pratimarsha nasya will be given 2 drops in each nostrils
Anupana- Oral medicine will be given with Ghrita and Madhu Route- Brihat Saraswat Churna- Oral Route Brahmi Tail Pratimarsha nasya- Nasal Route Randomization- Block randomization Duration of Study- 21 days with follow up of 21th day and 42th day Follow up- Every fortnightly during the study and 21 days after completion of the study
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
- 6.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Individual between age group of 6 to 15 years of both sexes 2 Individual satisfying Vanderbilt Assessment scale 3 Individual having borderline or more IQ will be considered.
排除标准
- •1 Individual below 6 years and above 15 years of age 2 Children with schizophrenia Bipolar Disorders Pervasive Developmental Disorders Oppositional Defiant disorders etc will be excluded from the present study 3 Children having genetic disorder 4 Children suffering from any severe or acute infections.
结局指标
主要结局
Brihat Saraswat Churna and Brahmi Taila Pratimarsh Nasya may be effective to ameliorate
时间窗: 21 Days
symptoms of Hyperactivity Disorder in 100 childrens
时间窗: 21 Days
次要结局
- 1 Brihat Saraswat Churna & Brahmi Taila Pratimarsh Nasya may be helpful to reduce dropouts from schools(2 Brihat Saraswat Churna & Brahmi Taila Pratimarsh Nasya may be provide a safe & effective treatment)
研究者
Dr Himanshu Soni
Post Graduate Institute Of Ayurved DSRRAU,Jodhpur