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临床试验/CTRI/2023/01/049123
CTRI/2023/01/049123尚未招募2 期

Randomized Comparative Clinical Study to evaluate the effect of Ashtanga Ghrita and Panchabhoutika Ghrita Pratimarsha Nasya on Speech in Autistic Children

Dr. Prakruthi R1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年1月25日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
40 components among 6 domains of ISAA(Indian Scale for assessment of Autism) will be assesed

研究概览

简要总结

Childhood is the period of physical, cognitive and social development that begins at birth and continues through early adulthood. Autism is one of the neurodevelopmental disorder characterized by difficulties with social interaction and communication; restricted and repetitive behaviour. About 1 in 100 children in India under the age of 10 have autism, and nearly 1 in 8 has at least one neurodevelopmental condition. Speech, language and communication skills are crucial to overall development of children. Being able to speak clearly, process speech sounds, to understand others, to express ideas and  to interact with others are fundamental building blocks for a child’s development.Children with Autism have difficulty in developing language skills, both in terms of comprehension and communication. They often have difficulty in communicating verbally and non-verbally. Speech impairment in autistic child, may lead to impairment in his/her socialization, education and behavior. Speech impairment affects social life negatively by affecting familial relationship and also interaction with children of their own age. It also has a negative impact on education leading to lowered academic expectations, limitations on teacher-child relationship. Because of behavioral changes of autistic children, parents find it difficult to take them to the social gatherings and send them to the normal school. Speech therapy may seems to promise more than it can deliver. Although this is by far the most desirable choice, some children may not easily acquire intelligible vocal speech. Autism is considered as the state of Jadatva (inertia) with Tamo avarana (covering with darkness) of Buddhi (intelligence), Manas (mind) and Vagindriya (sense organ of speech). Ayurveda mentions certain Yogas(formulations), which promote intelligible vocal speech by stimulating Vagindriya in Shiras. Among them Ashtanga ghritha  and Panchabhoutika ghrita , are few formulations which are said to enhance Vak, Medha, Smrithi etc.  As Nasa (nasal cavity) is the nearest route for Shiras, the drugs administered through Nasya will have a quicker effect on Vagindriya and helps in improving the 2 components of Vak. This study is an effort to evaluate the effect of Ashtanga ghrita and Panchabhoutika ghrita Pratimarsha Nasya on speech in autistic children.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Open Label

入排标准

年龄范围
5.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • 1.Children between 5-10 years of age diagnosed with autism as per DSM-5 criteria irrespective of gender, religion and socio-economic status. 2.Autistic children with speech defects will be included.

排除标准

  • 1.Children below 5 years and above 10 years of age.
  • 2.Children diagnosed with other Autism Spectrum disorders like Asperger’s disorder, Rett syndrome, Pervasive Developmental Disorder (PDD), Childhood Disintegrative Disorder, Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) etc.
  • 3.Children with other systemic illness will be excluded.

结局指标

主要结局

40 components among 6 domains of ISAA(Indian Scale for assessment of Autism) will be assesed

时间窗: 0th day | 45th day | 60th day

次要结局

  • Reduction in ISAA score will be assessed(45th day)

研究者

发起方
Dr. Prakruthi R
申办方类型
Other [self]

研究点 (1)

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