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临床试验/CTRI/2024/08/071895
CTRI/2024/08/071895尚未招募3 期

Evaluation of Saraswata churna with Panchbhautika taila nasya in the management of autism in children- a randomized controlled clinical trial

National Institute of Ayurveda Jaipur1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月1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
60
试验地点
1
主要终点
1.Change in ISAA score

研究概览

简要总结

Autism is a complex neuro-developmental disorder that tremendously affects the normal functioning of brain which challenges the child’s development. Autism is characterized by impaired communication (both verbal and nonverbal), impaired interpersonal social interaction and repetitive, restricted and stereotype mannerism of behavior or presence of unusually strong narrow interest. The presentation of these impairments is variable in range and severity and varies with the acquisition of other developmental skills.

According to WHO report, it is estimated that worldwide about 1 in 100 children have autismi. In India according to a report by ET Health World, about 18 million people in India are diagnosed with autism. About 1 to 1.5 percent of children aged 2 to 9 years are diagnosed with ASDii. Autism affects more male than female individuals. Etiology of autism is not yet known, but both genetic and environmental factors appear to play role. Environmental factors that may contribute to the etiology of ASD include pre or postnatal exposure to certain environmental chemicals and drugs, stress, maternal infection and dietary factors. Along with this, alteration in gut microbiota (gut dysbiosis) and other GI disorders are found in autistic children. That is derangement in digestive and metabolic system. Autism has close similarities to the features of that Unmada which is described in Ayurveda. The condition due to Dushta Dosha caused by the Mithyahara or Vihara consumption by an Alpa Satva person, which gets lodged in the Sthana of Buddhi, that is Hridaya and later does Margavarana of Manovaha Srotas leading to different lakshanas (manifestations). Looking to the manifestations of Unmada, some of them can be seen in autism spectrum disorders. These include involve impairments of -

Manas vibhramam – total or partial loss of sensory perception.

Buddhi vibhramam - intellect-partially affected –could be irregular as shown in savant skill.

Samjanajana vibhramam- impaired consciousness.

Smriti vibhramam –impaired memory.

Bhakti vibhramam- impaired desire, loss of innate quality of self-realization.

Seela vibhramam- socially inappropriate outbursts and adherence to strict rigid routines.

Chesta vibhramam- activities motor stereotype that are improper and compulsive.

Achara vibhramam- poor socialization skills, failure to obey orders, loss of healthy habits.

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 9.00 Year(s)(—)
性别
All

入选标准

  • Age between 03 to 09 years.
  • Diagnosed cases of Autism satisfying DSM 5/ AIIMS Modified INCLEN criteria (INDT- ASD) of either sex
  • Patients with score above 70 in Indian Scale for assessment of Autism (ISAA).

排除标准

  • ASD medications from any other system
  • Mental retardation, Cerebral palsy
  • Presence of other organic or psychotic neurological disorder
  • Pervasive developmental disorder
  • Hearing and visual impairment
  • Patients with acute and chronic systemic illness such as renal diseases, Hepatic dysfunction, Juvenile diabetes mellitus etc
  • Congenial disorders, Genetic syndromes like Fragile X syndrome, Turner syndrome etc
  • Progressive and non-progressive neuromuscular disorders
  • Endocrinal disorders, Protein Energy Malnutrition (PEM), Inborn error of metabolism.

结局指标

主要结局

1.Change in ISAA score

时间窗: baseline, 3 months

次要结局

  • 1.-Change in DSM V criteria(baseline, 3 months)

研究者

发起方
National Institute of Ayurveda Jaipur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Suman Devenda

National institute of ayurveda, jaipur

研究点 (1)

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