A Randomized Open Label Comparative Controlled Clinical Trial to evaluate the efficacy of Ashwagandhadi Taila with Occupational Therapy in the Management of Autism Spectrum Disorder in Children
概览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- Institute for Ayurved Studies and Research
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- It will be assessed on the basis of improvement in the domains of ISAA scale.
概览
简要总结
Autism Spectrum Disorder (ASD), understood in Ayurveda as a form of Unmada, is a neurodevelopmental condition that impairs communication, behavior, and social interaction in children. Conventional management is supportive, and there is still no definitive cure, which highlights the need for integrative approaches such as Ayurveda along with Occupational Therapy.randomized clinical study is planned to assess the effect of combining Occupational Therapy with Ayurvedic intervention (Ashwagandhadi Taila) in children with Autism Spectrum Disorder (ASD), correlated with Unmada in Ayurveda. The intervention group will receive Occupational Therapy along with Abhyanga, Nasya, Matra Basti, and Sneha Pana (three sittings of Abhyanga, Nasya and Matra basti for 16 days each, with Sneha Pana also continued for 16 days between the first and second sittings). The control group will receive only Occupational Therapy. The total study duration is 80 days, and assessments will be carried out before and after treatment using the Indian Scale for Assessment of Autism (ISAA) and the Autism Parenting Stress Index (APSI). This study aims to determine whether integrated Ayurvedic and Occupational Therapy provides additional benefits compared to Occupational Therapy alone in improving symptoms and reducing parental stress in ASD children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 9.00 Year(s)(—)
- 性别
- All
入选标准
- •Parents of children willing to participate in the research trial.
- •Diagnosed cases of Autism satisfying AIIMS modified INCLEN criteria.
- •Patients with score above 70 in Indian Scale for assessment of Autism (ISAA).
- •Children of age group 2-9 years.
- •irrespective of caste, sex, religion and socioeconomic status.
排除标准
- •Patients in age below 2 year and above 9 years.
- •One who doesn’t meet AIIMS modified INCLEN criteria and Patients with score below 70 in Indian Scale for assessment of Autism (ISAA).
- •Patients having mental retardation, cerebral palsy.
- •Patients having presence of other organic or psychotic neurological disorder.
- •Patients having hearing and visual impairment.
- •Patients having acute and chronic systemic illness such as renal diseases, hepatic dysfunction, juvenile diabetes mellitus etc.
- •Patients having genetic syndrome like fragile X syndrome, turner syndrome , Retts syndrome etc.
- •Patients having progressive and non-progressive neuromuscular disorders.
结局指标
主要结局
It will be assessed on the basis of improvement in the domains of ISAA scale.
时间窗: 80 days
次要结局
- Improvement in the feedback of Parents which will be assessed by Autism Parenting Stress(Index.)
研究者
Dr Pankaj Dahiya
Institute for Ayurved Studies and Research