Add on effect of selected ayurvedic treatment modalities in the management of Autism Spectrum Disorder in Children
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 3.Indian Scale for Assessment of Autism (ISAA)
研究概览
简要总结
This study is a Randomized parallel group open label clinical trial to assess the clinical efficacy of Ayurvedic treatment modalities in the Management of Autism Spectrum Disorder in Children. For that Mahapaishachik Ghrita will be orally administered 3-16 gm (as per age of child of 3-16 years) twice daily with luke warm water or milk for 3 months, Nasal instillation (Nasya) of Brahmi Ghrita 2 drops in each nostril once daily for 3 months, External application of oil over head (Shiroabhyanga) with Ksheer Bala Taila (10-20 ml) for 10 minutes for 3 months, Ayurvedic foot massage (Padabhyanga) with Ksheer Bala Taila (10-20 ml) for 10 minutes (5 minutes on each foot) will be done before going to bed for 3 months along with Non Pharmacological therapies in children suffering from Autism Spectrum Disorder.
To keep the transparency of distinguishing the exact effect of special treatment subject in trial group will be divided into two phases and treated i.e. Control group with only Non Pharmacological therapies for 6 months while Trial group treated with Non Pharmacological therapies for first 3 months (Phase I) and with Ayurvedic treatment modalities along with Non Pharmacological therapies for next 3 months (Phase II).
The primary outcome is reduction in the clinical features of Autism Spectrum Disorder and the secondary outcome will be changes in the quality of life of parents at 90 days and 180 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 3.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Fulfilling the diagnostic Criteria of Autism Spectrum Disorder according to -Diagnostic and Statistical Manual of Mental disorders Fifth edition (DSM-5TM)(299.00) -Childhood Autism Rating ScaleTM Second edition (CARSTM2) -Indian Scale for Assessment of Autism (ISAA) Parents/ Guardian willing to give informed written consent to participate in the study.
排除标准
- •Children below 3 years and above 16 years Presence of other organic or psychotic neurological disorder Hearing and visual impairment, Multiple disabilities Patients with acute and chronic systemic illness such as renal diseases, Hepatic dysfunction, Juvenile diabetes mellitus, malignancy, etc Progressive and non progressive neuromuscular disorders, Known neurodegenerative disorder Hypoxic Ischemic Encephalopathy (HIE) Endocrinal disorders, Protein Energy Malnutrition (PEM),etc Children taking anti-epileptic and anti-psychotic drugs.
结局指标
主要结局
3.Indian Scale for Assessment of Autism (ISAA)
时间窗: Baseline 0 day and 90 days and End of treatment 180 days
Reduction in clinical features of Autism Spectrum Disorder assessed by 1.Autism Treatment Evaluation Checklist (ATEC)
时间窗: Baseline 0 day and 90 days and End of treatment 180 days
2.Childhood Autism Rating Scale TM Second edition (CARSTM2)
时间窗: Baseline 0 day and 90 days and End of treatment 180 days
次要结局
- Changes in the quality of life of Parents