Randomized controlled clinical trial to study the effect of herbomineral formulation in autism spectrum disorder
概览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- Bharati Vidyapeeth (Deemed to be University)
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The primary outcome is to correct the impairment of social interaction and improve communication and imagination in children with ASD, along with the correction of repetitive behaviour, along with achievement of eye contact and being able to respond when called by name.
概览
简要总结
Autism is a disorder of neural development characterized by impaired social interaction and communication and by restricted and repetitive behavior. It is the commonest of the pervasive developmental disorders with considerable genetic etiological factors. Based on clinical features it can be correlated with Unmada (psychological disorder mentioned in Ayurvedic text book-Charaka Samhita). Manasa Mitra Vatakam is Manodoshahara and is indicated in all types of Mano Dosha, Prabala Unmada, etc. Animal studies done on Manamitra Vataka shows that it improves cognition, enhances long term memory, reduces anxiety, and improves behaviour. Manasamitra Vataka contains mineral components like Swarna Bhasma, Tamra Bhasma, Swarnamakshika Bhasma, Loha Bhasma, and Rajata Bhasma. A toxicity study of Manasamitra Vataka has been done on animals and is proved to be safe. Hence it is decided to study the effect of Manasamitra Vatakam and cognitive behavioral therapy on Autism Spectrum Disorders (ASD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Children of either gender, aged between
- •10 years b) Diagnosed with Autism spectrum disorder(Diagnostic and Statistical Manual of Mental Disorders V criteria) c) Children in the vicinity of the Dhankawadi area. d) Parents who are willing to give consent for the child’s participation in the study.
排除标准
- •a) Children on anti-epileptic medications.
- •b) ASD medications from any other disciplines for more than 1 week.
- •c) Children with co-morbid conditions like cerebral palsy, mental retardation or any other chronic neurological or metabolic disorders.
- •d) Known case of any known syndrome.
结局指标
主要结局
The primary outcome is to correct the impairment of social interaction and improve communication and imagination in children with ASD, along with the correction of repetitive behaviour, along with achievement of eye contact and being able to respond when called by name.
时间窗: 90 days
次要结局
- Secondary outcome is acquisition of speech and language(90 days)
研究者
Dr Preetham Pai
College of Ayurved, Bharati Vidyapeeth (Deemmed to be University)