Phase II Non Randomized Clinical Study In The Management Of Maantha Sanni (Autism Spectrum Disorder) With The Validation Of Siddha Trial Drug Maantha Kuligai As Internal Medicine And Sanni Maantha Pugai As (External)
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 Maantha Kuligai(internal) is to be given about 1(145mg) to 2 (290mg) (Thuvarai alavu) tablet(kuligai) with hotwater twice a day for 48 daysand External Fumigation of Sanni Maantha Pugai for 48 days. clinical trial conducted after conducting preclinical study.The Trial drug Maantha Kuligai mentioned in Bala vaithiya thirattu and Saani Maantha Pugai mentioned in Pillai Pini Maruthuvam part 2. During the trial the study related data will be recorded and documented.After the completion of trial all 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
- 2.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children have lack of eye contact Lack of response Repetitive and restrictive behavior Unawareness of natural urges Acquired speech or lost it Unusual sensitive to sensory stimuli.
排除标准
- •Children above 12 years Children below 2 years Severe and recurrent seizure ADHD Cerebral palsy Infantile hemiplegia Congenital anomalies.
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 sensory function connecting parameters social interactions adaptive behavior language communication domains(48 Days)
研究者
Dr M Soundarya
Government Siddha Medical College Arumbakkam Chennai 106