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临床试验/CTRI/2025/12/099634
CTRI/2025/12/099634尚未招募不适用

EVALUATION OF KUSHTHADI GHRITA ALONGWITH PANCHBHAUTIKA TAILA PRATIMARSHA NASYA AND OCCUPATIONAL THERAPY IN THE MANAGEMENT OF AUTISM SPECTRUM DISORDER IN CHILDREN- A RANDOMIZED CONTROLLED TRIAL

National Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年8月14日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1

研究概览

简要总结

Autism Spectrum Disorder (ASD) is a complex neurodevelopmental condition characterized by deficits in social interaction, communication, and restricted, repetitive behaviors, with onset in early childhood. The rising prevalence of ASD and the limitations of conventional therapies necessitate the exploration of integrative, evidence-based treatment approaches. Ayurveda describes conditions comparable to ASD under Unmada and Vata Vyadhi, attributed to derangement of Dosha affecting Manovaha Srotas and Buddhi.

The present study aims to evaluate the efficacy of Kushthadi Ghrita orally along with Panchabhautika Taila Pratimarsha Nasya combined with Occupational Therapy, compared to Occupational Therapy alone, in the management of ASD in children aged 3–12 years.

This is an open-label, prospective, randomized controlled trial conducted at the National Institute of Ayurveda, Jaipur. A total of 30 children diagnosed with ASD (ISAA score >70) will be randomly allocated into two groups: Group A receiving Ayurvedic interventions along with occupational therapy, and Group B receiving occupational therapy alone, for a duration of 12 weeks.

The primary outcome measure is change in the Indian Scale for Assessment of Autism (ISAA) score, while secondary outcomes include changes in clinical features of ASD as per DSM-V-TR and Ayurvedic parameters. Statistical analysis will be performed using appropriate non-parametric tests.

This study seeks to generate clinical evidence for a holistic, integrative approach combining Ayurvedic therapeutics and occupational therapy, potentially offering a safe, effective, and sustainable management strategy for children with ASD.

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 12.00 Year(s)(—)
性别
All

入选标准

  • Children between the age group of 3-12 years of either sex.
  • Those meeting DSM V TR and AIIMS modified INCLEN criteria Indian scale for assessment of Autism Score (ISAA) more than 70.

排除标准

  • One who doesn’t meet DSM V TR and AIIMS modified INCLEN criteria Children having any other psychotic or neurological disorder.
  • Children having any co-morbid conditions or congenital disorder or genetic syndromes like Rett’s Syndrome .

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Amar Marode

National Institute of Ayurveda

研究点 (1)

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