Non Randomised contolled trial on the add-on effect of Kolakulathadi pradeham in Sensory Processing Dysfunction associated with Autism Spectrum Disorders in children of age group 3-12 years
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in scores in various domains of Sensory profile 2 including auditory, visual, olfactory,tactile, vestibular or multisensory processing
研究概览
简要总结
Non Randomized Controlled Trial will be carried out after 32 subjects satisfying the inclusion criteria are selected and control group given Kalyanaka ghrita and parental advise for sensory integration exercises by an occupational therapist.and trial group with Kolakukathadi pradeha along with Kalyanaka ghrita and parental advise for sensory integration exercises by an occupational therapist.Kalyanaka ghrita will be given internally(10-20ml) in divided dose twice daily and Kolakukathadi choorna processed in Bala ksheera along with Dhanwantaram tailam will be used for pradeha externally over the skin.Period of intervention is 28 days and blinded asessment will be done before and after the treatment by an occupational therapist using Sensory Profile 2 and effect of intervention on social relation and reciprocation,emotional responsiveness, speech-language and communicaton,behaviour patterns,sensory aspects,cognitive component will be assessed using Indian Scale for Asessment of Autism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.3-12 year old children satisfying the DSM 5 criteria for Autism Spectrum Disorder 2.Children with a score in the definite or probable difference range in one or more domains of the Sensory Profile 2.
排除标准
- •1.Other forms of ASD like Aspergers Syndrome, PDD NOS.
- •2.Children with Neuro Degenerative Disorders.
- •3.Children with intractable epilepsy.
- •4.Children with eruptive skin lesions.
- •5.Children with profound hearing and visual loss clinically.
结局指标
主要结局
Change in scores in various domains of Sensory profile 2 including auditory, visual, olfactory,tactile, vestibular or multisensory processing
时间窗: before and after 28 days of intervention, after follow up period of 14 days
次要结局
- Changes in the scores in social relation and reciprocation,emotional responsiveness,speech-language and communicaton,beahiour patterns,sensory aspects,cognitive component will be asessed using Indian Scale for Asessment of Autism(before and after 28 days of intervention, after follow up period of 14 days)
研究者
Dr Arsha Unni
Govt. Ayurveda College Trivandrum, Kerala- 695001