跳至主要内容
临床试验/CTRI/2025/07/090617
CTRI/2025/07/090617
尚未招募
3 期

Randomized comparative clinical study to evaluate the efficacy of Panchendriyavardhana Ghrita Pratimarsha Nasya and Amalaki Avaleha orally in Indriyapradoshaja Vikaras with special reference to Sensory Processing Disorders in children with Autism

Shruti K1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月15日最近更新:

概览

阶段
3 期
状态
尚未招募
发起方
Shruti K
入组人数
30
试验地点
1
主要终点
Primary outcome :

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. Childhood is a time of imagination and creativity. Sensory experiences in childhood play a vital role in developing neural connection and pathways that are essential for learning, memory and overall cognitive development.

Autism comprises of multiple deficits that are yet to be understood, one of them being the sensory difficulties which are collectively termed as Sensory Processing Disorders (SPD). Rate of Sensory Processing Dysfunction may be as high as 90% in individual with autism.The abnormal sensory reactivity is associated with severity of autism, poor functional outcomes and behavioural difficulties including anxiety disorders across the lifespan. Early characterization of sensory abnormalities would be of tremendous value for guiding therapeutic interventions.

But in practice it is observed that the prime focus of parents and medical fraternity in the management of autism lies in the initiation of speech and correction of social behaviour, Sensory Dysfunction being paid less attention most of the times. Sensory Integration Therapy is a gold standard approach aimed at improving Sensory Processing in such children. Several studies are conducted in Ayurveda on Autism, but they lack a specific approach to sensory dysfunction.

SPD can be considered as Indriyapradoshaja Vikaras mentioned in Ayurveda where there is Upatapa (Vaikalya - Partial loss of function or altered function) and Upaghata (Nasha- Total loss of Functions, may be Permanent or Temporary) of Indriyas that leads to the

 dysfunction of sensory pathways.

(3) (4)

Indriyapradoshaja Vikaras may be treated on lines of Shiromarma Chikitsa as well with Rasayana Dravyas which facilitate the restoration of sensory functions. Shiromarma Chikitsa includes Nasya, Abhyanga, Snehapana etc. There are several Rasayana Yogas mentioned in classicswhich are said to be Buddheendriyabalaprada (Strengthening the sensory organs), few of them being Amalaki Avaleha, Amalaki Churna, Amalaki Ghrita, Panchama Haritaki Yoga, And Panchendriyavardhana Ghrita. These Yogas may be administered in the form of Nasya or orally as indicated which can correct the deranged function of Indriyas and their entire pathway. Thus, considering the fact that the sensory abnormalities in Autism and its remedies are unexplored through Ayurveda andaspecialized approach to SPD is the need of the day, two different approaches are planned to be studied in SPD.

Thus, the current study is aimed at finding the efficacy of Panchendriyavardhana Ghrita Pratimarsha Nasya and Amalaki Avaleha orally in Sensory Processing Disorders, with special reference to Indriyapradoshaja Vikaras in children with Autism.

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
3.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • 1.Subjects between the age group of 3year – 6 years.
  • Subjects diagnosed with autism through DSM 5 criteria.

排除标准

  • 1.Subjects who are known case of ADHD and the other syndromes will be excluded.
  • Subjects who are known case of other systematic illness will be excluded.

结局指标

主要结局

Primary outcome :

时间窗: 0th day, 30th day, 60th day, 90th day

Significant improvement in Indriyapradoshaja Vikaras with special reference to Sensory Processing Disorders in children with Autism assessed on Child Sensory Profile 2.

时间窗: 0th day, 30th day, 60th day, 90th day

Secondary outcome :

时间窗: 0th day, 30th day, 60th day, 90th day

Generation of in – depth analyzed data on the different aspects of the disease .

时间窗: 0th day, 30th day, 60th day, 90th day

Generation of data on possible unexpected drug reaction.

时间窗: 0th day, 30th day, 60th day, 90th day

次要结局

  • Secondary outcome :(Generation of in – depth analyzed data on the different aspects of the disease .)

研究者

发起方
Shruti K
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Shruti K

Sri Sri College of Ayurvedic Science and Research Hospital Banglore.

研究点 (1)

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