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临床试验/CTRI/2025/03/083299
CTRI/2025/03/083299尚未招募不适用

Designing and Validation of a Preliminary Diagnostic Tool for Unmada W.S.R to Autism Spectrum Disorder

未提供1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
A Reliable and Validated Preliminary Diagnostic Tool for Unmada w.s.r to Autism Spectrum Disorder

研究概览

简要总结

Unmada encompasses a range of psychosomatic mental disorders affecting the Manovaha Srotas, defined by derangement in eight domains: Mana (thinking process), Buddhi (intellect), Sanjnajnana (consciousness), Smriti (memory), Bhakti (desire), Sheela (temperament), Chesta (behavior), and Achara (conduct).

Correlation with Autism Spectrum Disorder (ASD) ASD exhibits similarities to Unmada and can be better understood through these eight domains. ASD is the third most common developmental disorder globally, with a prevalence of 1 in 110 children in India. It is characterized by impairments in social interaction, communication, and repetitive behaviors. The etiopathogenesis is multifactorial, involving genetic and environmental factors.

Significance of a Diagnostic Tool Modern systems like DSM-5 and ICD provide diagnostic criteria, but Ayurveda identifies conditions based on Pratyatma Lakshana (cardinal features) and Dosha predominance. Minimal work has been done to integrate these perspectives into a unified diagnostic tool for Unmada with respect to ASD. Developing and validating such a tool can standardize diagnosis and improve clinical utility.

Methodology A scale incorporating Ayurvedic and modern diagnostic principles will be developed and validated. Literature will be reviewed, and items categorized into eight domains. The scale will undergo face, content, and construct validation by experts and will be tested for internal consistency using Cronbach’s alpha. External consistency will be assessed through test-retest and inter-rater reliability.

Study Design The study involves observational assessment of 50 diagnosed ASD patients (ages 3–18) at SDM College of Ayurveda, Udupi. Validation will include comparison with the Indian Scale for Assessment of Autism (ISAA).

Inclusion Criteria Diagnosed ASD cases accompanied by consenting guardians.

Exclusion Criteria None, as the study is observational.

Duration 15 days.

研究设计

研究类型
Observational

入排标准

年龄范围
3.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed ASD patients from the age group of 3 to 18 years, who are accompanied by a parent/ legal guardian from Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Udupi.
  • Parent / legal guardian of the patient, who are ready to give the assent.

排除标准

  • As there is no intervention and diagnosed case of ASD patients are taken, no exclusion parameters will be considered.

结局指标

主要结局

A Reliable and Validated Preliminary Diagnostic Tool for Unmada w.s.r to Autism Spectrum Disorder

时间窗: 1st day | 8th day | 15th day

次要结局

  • Developing a diagnostic tool will bring uniformity in(diagnosis, prognosis along with standardization in clinical approach has become the need of hour)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr. Manisha U K

Sri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady, Udupi.

研究点 (1)

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