CTRI/2025/04/084274尚未招募Phase 3 4
Two Arm Open Label Prospective Clinical Study to Evaluate the Efficacy of Shankhapushpi Syrup with and without Applied Behavior Analysis Therapy in Autism Spectrum Disorder in Children
Post Graduate Institute of Ayurved DSRRAU Jodhpur1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年4月7日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Shankhpushpi Syrup with and without Applied Behavior
研究概览
简要总结
Number of Patient- 40
Type of Study- Two Arm Open label Prospective Clinical Study
Group :- Two Groups:-
Group A :- Shankhpushpui syrup
Group B - Shankhpushpui syrup with Applied Behavior Analysis Therapy
Drug- Shankhapushpui syrup
Dose- Dose will be calculated according to Young Formula in three divided doses.
Route- Shankhpushpui syrup - Oral Route
Anupana- Oral medicine will be given with Luke warm milk
Randomization- Simple Random Sampling
Duration of Study- 60 days
Follow up- Every fortnightly during the study and 120 days after completion of the study.
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 16.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Diagnosed cases of Autism satisfying DSM V criteria of both sexes 2 Patients with score above 70 in Indian Scale for assessment of Autism (ISAA) 3 Age between 3 to 16 years of both sexes.
排除标准
- •1 Patient with score below 70 in Indian Scale for assessment of Autism (ISAA) 2 ASD medications from any other system 3 Patients having mental retardation, cerebral palsy 4 Patients having presence of other organic or psychotic neurological disorder 5 Patients having pervasive developmental disorder 6 Patients having hearing and visual impairment 7 Patients having acute and chronic systemic illness such as renal diseases, hepatic dysfunction, juvenile diabetes mellitus etc 8 Patients having congenial disorders, genetic syndrome like fragile X syndrome, turner syndrome etc 9 Patients having progressive and non-progressive neuromuscular disorders.
结局指标
主要结局
Shankhpushpi Syrup with and without Applied Behavior
时间窗: 60 Days
Analysis Therapy will be effective.
时间窗: 60 Days
次要结局
- 1. Shankhpushpi Syrup with and without Applied Behavior Analysis Therapy will(be helpful to improve quality of life of children suffering from ASD.)
研究者
Dr Kamlesh Kumar Meena
Post Graduate Institute of Ayurveda Jodhpur
研究点 (1)
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