Pre-Clinical and Clinical Studies On the management Of Cerebral Palsy (Sirakamba Vatham) in Children Using The Siddha Formulations Vani Vallarai Nei (Internal) and Chitramutti Madakuthylam (External) – A Multi centric study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Safety and efficacy of the trial drug will be analyzed by Preclinical studies.
研究概览
简要总结
Cerebral palsy places a heavy burden on families and health systems. This is an open-label, non-randomized control study on Cerebral palsy (Sirakamba Vatham) to evaluate the official Siddha formulations Vani Vallarai Nei (internal) and Chitramutti Madakuthylam (external). The children took internal (twice a day) and external (once a day) medicines for 90 days, and improvement will be compared for the control group. The present study will provide a better direction by improving the quality of life of children and their life expectancy.
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 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of Spastic type of cerebral palsy (Sirakamba vadham) Parents/Guardians giving informed consent (signed witnessed, according to local regulations) before any protocol specific procedures.
排除标准
- •K/C/O Ataxic/ Dyskinetic /Athetoid/ choreoathetoid / dystonic CP Mixed type of Cerebral Palsy CP child with Spinal deformities ASD/ADHD(Hyper activity) Blindness, Down Syndrome, Spina Bifida, Traumatic Brain Injury Severe and/or Multiple Disabilities & Children with H/o bleeding tendencies, cirrhosis and oesophageal Varices.
结局指标
主要结局
Safety and efficacy of the trial drug will be analyzed by Preclinical studies.
时间窗: 90 days
Improvements in the Clinical conditions will be measured by Assessment scale.
时间窗: 90 days
次要结局
- Intervention efficacy assessed by the Siddha Diagnostic parameter.(90 days)
研究者
Dr S Shakila
National Institute of Siddha,