跳至主要内容
临床试验/CTRI/2024/12/078568
CTRI/2024/12/078568尚未招募3 期

Randomized comparative clinical study to evaluate the efficacy of Jeevaneeya Ghrita Pratimarsha Nasya and Marma Chikitsa in children with Autism with special reference to social relationship and emotional responsiveness

Dr N Logeshwaran1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月30日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Significant improvement in social relationship and emotional responsiveness in children with Autism assessed based on Indian Scale for Assessment of Autism (ISAA)

研究概览

简要总结

•Autism is a developmental disability caused by hypoconnectivity in the brain . People with ASD experience myriad of  difficulties in communicating with others or understanding social cues.

•Autism is characterized by difficulties in initiating social interaction and communication; restricted interests and repetitive behavior which poses a great challenge to individuals and to societies not just in early ages but across lifespan due to its pervasive nature.

•Autism is the third most common developmental disorder. According to WHO, it is estimated that worldwide about 1 in 100 children has autism. In 2021 About 1 to 1.5 % of children aged 2 to 9 years are diagnosed with ASD, In 2023 about 18 million people in India are diagnosed with Autism.

•Social deficits in autism include initiating interaction, responding to initiations, maintaining eye contact etc. these social deficits make it difficult for the child to develop personal relationships, peer rejection, anxiety, depression etc.

•Along with social deficits they also face difficulties in emotional regulation and processing leading to difficulty in identifying and attributing emotions, lack of pragmatic understanding etc.

•Autism in Ayurveda is an Anuktha Vyadhi and it can be nearly considered under a state of Unmada spectrum conduct disorder where there is defective endowment called pervasive disorder or Jadatwa. This is dominated by complete Buddhi Nirodha by Tamoguna.

•Along with Manasika Doshas, Shareerika Doshas also play an important role in stabilizing the Manas and Indriyas. The balanced state of Pitta and Vata helps to control emotional imbalances and promotes wise social interaction. Jeevaneeya Ghrita mentioned in Pittaja Unmada is one such Yoga which promotes above benefits by its Madhura , Tikta, Snigdha , Brimhana , Ojasya properties.

•Administration of Jeevaneeya Ghrita in the form of Pratimarsha Nasya is more beneficial, as Nasa (nasal cavity) is the nearest route for Shiras, the drug administered through Nasa will have a quicker effect on Shirohridaya and helps in reducing Pittavataja Lakshanas of Unmada.

•There are certain special points called as Marma Sthanas in the body which control the endocrinal , neuromuscular activities of the surrounding areas . Stimulation of these Marmas facilitates the removal of Srotorodha and proper flow of energy resulting in cure of diseases. Marma Chikitsa is an emerging branch of supportive therapy which focuses on systematic stimulation of Marmas for achieving therapeutic effect.

•Clinically, performance of Marma Chikitsa on Sthapani Marma (Thilartha kalam) has shown improvement in clinical features of autism, but its effectiveness is not validated systematically.

•There is a strong need for intervention on developing the social skills and regulation of emotional states in children with ASD as they have life long implications and are extremely difficult to learn.

•Thus the current study aims at improving the emotional responsiveness and social relationship of children with autism by the use of Pittahara Brimhana Ghrita Pratimarsha Nasya and Marma Chikitsa and validating the findings on a standard scale.

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 8.00 Year(s)(—)
性别
All

入选标准

  • 1.Children in the age group of 3 years – 8 years 2.Children diagnosed with mild to moderate Autism , irrespective of their gender, religion and socio-economic status will be included.
  • 3.Children in whom parents are willing to sign the written consent form will be included.

排除标准

  • 1.Children who are known case of ADHD and the other syndromes associated with ASD such as Asperger’s syndrome, Rett syndrome, childhood disintegrative disorder, Kanner’s syndrome and Anxiety disorder, Mental Retardation, will be excluded.
  • 2.Children with other chronic systemic illnesses will be excluded.

结局指标

主要结局

Significant improvement in social relationship and emotional responsiveness in children with Autism assessed based on Indian Scale for Assessment of Autism (ISAA)

时间窗: 0-30-60-90 th day

次要结局

  • 1.Generation of in – depth analysed data on the different aspects of the disease.(2.Generation of data on possible unexpected drug reaction or of Marma Chikitsa.)

研究者

发起方
Dr N Logeshwaran
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr N Logeshwaran

Sri Sri College of Ayurvedic Science and Research

研究点 (1)

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