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临床试验/CTRI/2025/04/084976
CTRI/2025/04/084976尚未招募不适用

Development and Validation of Diagnostic Tool for Janu Sandhigatavata with Special Reference to Knee Osteoarthritis

未提供1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年5月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
140
试验地点
1
主要终点
Developing Ayurveda standardized diagnostic methods and tools, particularly for disease diagnosis and clinical practice and ensure the reliability and validity of Ayurvedic clinical practices.

研究概览

简要总结

•The majority of ayurvedic clinical studies conducted today use generic instruments that are based on references from traditional texts, even if they haven’t been properly validated. Additionally, given that the pathological concepts of Ayurveda are based on the functional derangements of dosha, there are also no established goldstandards like histopathology, for validating these tools. Hence,there is a need for developing and validating diagnostic tools for diseases enumerated in Ayurveda, to standardise the clinical approach, even when attempting for a patient-centric, individualised diagnosisCurrently, no diagnostic tools are available for an ayurvedist to identify this clinical entity and many a time, the situation is overlooked. Hence, developing a comprehensive clinical profile and a diagnostic tool is the need of the hour for offering precise clinical solutions. the study aims To develop and validate diagnostic tool for Janu sandhigatavata as per principles and practice of Ayurveda and the objectives are 1.To Diagnose sandhigata vata using ayurvedic and modern diagnostic tool. 2.To develop and validate diagnostic tool/process for Janu sandhigatavata (Knee Osteoarthritis).The study employs a mixed-methods approach to develop and validate a diagnostic tool for Janu Sandhigatavata. Conducted in four phases, it begins with defining diagnostic criteria and formulating questionnaire items through literature reviews, expert surveys, and focus group discussions. Phase II involves pre-testing the tool for respondent friendliness, face/content validity, and translation equivalence. Phase III focuses on refining the tool through expert input and domain reduction. Phase IV assesses the tool’s reliability (inter-rater and internal consistency) and clinical validity against expert panel diagnoses using statistical methods like Kappa statistics and Cronbach’s alpha. Additionally, an analytical study of Janu Sandhigatavata determinants will be conducted on 140 participants, adhering to strict inclusion and exclusion criteria. Ethical approval, informed consent, and Good Clinical Practice guidelines will ensure compliance with ethical standards. Statistical analyses include chi-square tests, regression, and descriptive statistics, with significance set at 5%. The study will be completed within 3–4 years at KAHER’s Ayurveda Mahavidyalaya, Belagavi.

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Subjects presenting with the classical symptoms of sandhivata.

排除标准

  • Developed as a complication of systemic disease like Thyroid Asthma Malignancies Liver disorders Uncontrolled hypertension uncontrolled diabetes mellitus & Chronic renal failure.
  • No Trauma infections and tumours Patients with classical symptoms of Amavata and vatarakta.

结局指标

主要结局

Developing Ayurveda standardized diagnostic methods and tools, particularly for disease diagnosis and clinical practice and ensure the reliability and validity of Ayurvedic clinical practices.

时间窗: Baseline

次要结局

  • Understand determinants(nidana) of Janu sandhi gata vata(Baseline)

研究者

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

Hemlata Shete

KAHER Shri BMK Ayurveda Mahavidyalaya

研究点 (1)

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