Clinical efficacy of Ashtamangala ghrita in Autism Spectrum disorder w.s.r to Unmad in children -An open labelled single arm clinical study
概览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- Dr Namita Jadhav
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in the clinical features of Autism spectrum disorder assessed by using DSM 5 ,Unmad samanya lingam and ISAA criteria for autism spectrum disorder.
概览
简要总结
Autism is a type of neurobiological disorder with key features like impairment in social communication and interaction accompanied by restricted and repetative behaviour .Autism spectrum disorder is the new name of four previously separate disorders. Autism spectrum disorder now encompasses the previous DSM – IV ,Classical autistic disorder i.e Autism , Asperger’s disorder, Childhood disintegrative disorders and Pervasive developmental disorders .In Ayurveda by examining the features of ASD it shows similarities with the symptoms of Unmad and considering etiopathogenesis involved in ASD, there is need for medications and therapies which focus not only the higher centers of the brain, but the body with mind . Manovaha srotodushti together with Tridosha dushti is the basic cause of childhood autism spectrum disorder. Along with other etiological factors, impaired digestive and metabolic functions are postulated as the root cause of Unmad. accord with the gut brain axis, systemic accumulation of metabolic wastes also disrupts the functional integrity of the brain . Ashtamangala Ghrita is a polyherbal formulation mentioned in Bheshajyaratnavali balrogadhikar chapter ,have medhya properties and can improve memory ,intellect and cognition in children ,drugs like pippali ,sariva ,kushtha helps to maintain normal gut flora ,preventing from gut dysbiosis.The study aimed to determine effect of Ashtamangala Ghrita in reducing symptoms of Autism spectrum disorder, by using Assessment tools like DSM V , ISAA ,and Unmad Samanya lingam.
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.Patient diagnosed with Autism spectrum disorder according to DSM 5 criteria (Patient fulfilling all three lakshanas from social communication domain , and two out of the 4 behavioural symptoms ) , irrespective of sex, religion,etc.
- •2 .Children aged 3 to 16 years.
- •fulfilling at least 3 out of 6 lakshanas from unmad samanya lingam criteria.
排除标准
- •1.Patients suffering from other complications like cerebral palsy, mental retardation, seizures, ADHD ,Rettts syndrome .
- •Severe comorbid psychiatric illness.
- •Child suffering from any Systemic illness.
结局指标
主要结局
Reduction in the clinical features of Autism spectrum disorder assessed by using DSM 5 ,Unmad samanya lingam and ISAA criteria for autism spectrum disorder.
时间窗: 1st follow up -On 30nth day of treatment | 2nd follow up -On 15th day after completion of treatment
次要结局
- 1) To study effect of Ashtamangala ghrita, on reducing Autism spectrum disorder symptoms.(2) To compare pre- and post-intervention outcomes using standardized assessment tool to determine the)
研究者
Dr Namita Jadhav
Dr G D Pol Foundation YMT Ayurved college Kharghar Navi Mumbai Maharashtra