CTRI/2023/09/057888尚未招募2 期
Phase II Non-randomized clinical study on Sirakambavatham (Cerebral palsy) with the evaluation of siddha trial drug Parangipattai kashayam as Internal medicine and Sneha pottanam (Ottradam) as External therapy.
Government Siddha medical college1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年5月10日最近更新:
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 Parangipattai kashayam (Internal) is to be given about 5 to 10 ml twice a day for 48 days and External therapy of Sneha pottanam (Ottradam) on the affected area for 48 days. Clinical trial conducted after conducting Pre clinical study. The trial drug Parangipattai kashayam and external therapy Sneha pottanam (Ottradam) has mentioned in Pillaipini vagadam. During the trial study related data will be recorded and documented. After the completion of trial all data will be statistically analysed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 3.00 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 quadriplegic cerebral palsy.
排除标准
- •Children above 12 years.
- •Patient with severe seizure disorder.
- •Patient with severe serious illness.
- •CP with other congenital associated disorders.
- •Autism spectrum disorders.
- •Mixed type of cerebral palsy.
- •Ataxic/Dyskinetic/Athetoid/Choreoathetoid/Dystonic cerebral palsy.
结局指标
主要结局
It is mainly assessed by reduction in clinical symptoms
时间窗: 48 days
次要结局
- It is assessed by comparing the sensory functions connecting parameters & improvement in motor parameters and fine motor functions of the upper limb.(48 days)
研究者
研究点 (1)
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