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临床试验/CTRI/2024/03/064400
CTRI/2024/03/064400尚未招募1/2 期

Evaluation of Ayurveda Treatment Protocol in management of Autism in children – A Randomised Clinical Trial

KLE Ayurveda Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月30日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
To evaluate the effect of ayurveda treatment protocol

研究概览

简要总结

Autism is a heterogeneous neurodevelopmental condition manifesting in early childhood. [1]The abilities and needs of people with autism vary. While some can live independently , most of the them will have severe disabilities and require lifelong care and support. According to WHO, It is an emerging global concern with 1 in 160 children diagnosed with autism[1] . In India, 01 in every 88 children is diagnosed with Autism[2]. It is approximately four times more common in males than females.

At present no  medications  are established  to  treat its core  symptoms. Risperidone and Aripiprazole are the only FDA approved medication targeting the irritability seen with this diagnosis. Moreover, Children and adolescents with autism appear to be more susceptible to adverse effects with these medications[3]. The line of treatment commonly used is speech therapy, psychotherapy, occupational therapy, behaviour training and dietary modification. These treatments are time consuming and need of much manpower. Because of all the above reasons, there is a need to find a new approach and modality for Autism.

In Ayurveda, the autism can be understood under the concept of Unmada. In this study, we are planning the Ayurveda  Panchakarma treatment protocol  which includes sarvanaga Abhyanga, Nasya, matrabasti and shrotalam which will be beneficial in autistic children. Hence an effort is made to evaluate the effect of Ayurveda treatment protocol in autism in specified number of samples.

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • Children of either sex between the age group of 3yrs-16 yrs Children satisfying DSM5 diagnostic criteria for autism will be included for the study.

排除标准

  • At the time of enrollment, if the child is found to be non-inclusive due to underlying health condition or medication will be excluded Children with any acute or chronic,local or systemic infection will be excluded.
  • Children with any Congenital malformations will be excluded Children who are currently under any other medications will be excluded At the time of enrollment,if the child is found to be no n inclusive due to underlying health condition or medication will be excluded Children with any acute or chronic,local or systemic infection will be excluded.
  • Children with any Congenital malformations will be excluded.

结局指标

主要结局

To evaluate the effect of ayurveda treatment protocol

时间窗: To evaluate the effect of ayurveda treatment protocol | and to improve the quality of | life | Time points - 7 th day , 38 th day

and to improve the quality of life

时间窗: To evaluate the effect of ayurveda treatment protocol | and to improve the quality of | life | Time points - 7 th day , 38 th day

次要结局

  • There might be effect of ayurveda treatment protocol(0th day - enrollment)

研究者

发起方
KLE Ayurveda Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Kaveri Hulyalkar

KAHER shri BMK Ayurveda Hospital , Belagavi

研究点 (1)

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