An open single arm,single centric clinical trial to evaluate the effectiveness of siddha therapeutic management of sanni kiyaazham (internal) and varmam (external) for Alathidu sanni (Attention deficit hypertensive disorder)in children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess the effectiveness of sannikiyaazham( internal) & varmam(external)
研究概览
简要总结
This is an open clinical study to evaluate the effectiveness of sanni kiyaazham(internal)and varmam(external) for the management of Alathidu sanni(ADHD)in children.It is characterized by symptoms of inattention,overactivity,impulsiveness that are age inappropriate.A sample of 30 subjects (both male and female)with the symptoms of Alathidu sanni (ADHD) who are visiting at national institute of siddha OPD and IPD are to be selected as per inclusion and external criteria.After obtaining consent,the participants will be enrolled in the study.The trial drug will be prepared in the Gunapaadam laboratory,national institute of siddha.the enrolled patients will be treated with trial drug sanni kiyaazham and varmam for 48 days and prognosis will be assessed after 7 days.The data will be analayzed using statistical analysis method.The outcome will be assessed using conner’parents rating scale and conner’s teacher rating scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 2.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children of age group under
- •12 years Clinically diagnosed as a ADHD Meet the diagnostic symptoms (any of three) Lack of concentration Talking nonstop Blurting things out Frequent jumping from one task to another • Being easily distracted • Hyperactivity • Trouble sitting still • Inability to react to other people’s emotions or feelings.
排除标准
- •seizure disorder Cerebral palsy Autistic spectrum disorder Auditory and visual processing disorder.
- •Neurodegenerative disorder.
- •Post-traumatic head injury.
- •Post encephalitic disorder.
结局指标
主要结局
To assess the effectiveness of sannikiyaazham( internal) & varmam(external)
时间窗: 1 year
for the management of AlathiduSanni (Attention deficit Hyperactive Disorder) in children by using
时间窗: 1 year
Conner’s parents rating scale & conner’s teachers rating scale.
时间窗: 1 year
次要结局
未报告次要终点