Phase II Non Randomized Clinical Study In The Management Of Sirakambavatham (Cerebral Palsy) With The Validation Of Siddha Trial Drug Sirakambavathathirkku Kudineer As Internal Medicine And Saranai Thailam As External Therapy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- It is mainly assessed by reduction in clinical symptoms
研究概览
简要总结
This is a single Non-Randomized Open Clinical Trial to study the safety and efficacy of siddha trial drug Sirakambavathathirkku Kudineer (internal medicine) is to be given about 5-10 ml twice a day for 60 days and External therapy of Saranai Thailam (thokkanam) on the affected area for 60 days.Clinical Trail conducted after conducting Pre clinical study. The trial drug Sirakambavathathirkku kudineer is mentioned in Agathiyar Vaithiya Sinthamani and External therapy saranai thailam (Thokkanam) is mentioned in Agathiyar Vaithiya Pooranam 205.During the study related data will be recorded and documented .After the completion of the trial all the data will be statistically analyzed.
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
- 1.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Delay in gross motor and fine motor milestones Delay in intellectual and cognitive functional development Abnormal muscle tone and reflexes spastic cerebral palsy.
排除标准
- 未提供
结局指标
主要结局
It is mainly assessed by reduction in clinical symptoms
时间窗: 60 days
次要结局
- It is assessed by comparing the sensory functions connecting parameters and fine motor functions of the upper limb(60 days)
研究者
Dr M Kamali
Government Siddha Medical College Arumbakkam Chennai 106