Determining the Accuracy of Naadi (Siddha Pulse ) Examination in Detecting the case of Pulmonary Pathology Reporting at National Institute of Siddha- A Prospective Blinded Clinical Diagnostic Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 348
- 试验地点
- 1
研究概览
简要总结
Naadi Siddha Pulse examination is a traditional Siddha diagnostic method based on pulse assessment This study aimed to evaluate its diagnostic accuracy in detecting the participants with Pulmonary pathology using Spirometry as the reference standard
PRIMARY OBJECTIVE
To determine the diagnostic accuracy of Naadi Siddha pulse examination in the detection of participants with Pulmonary pathology
SECONDARY OBJECTIVES
To determine the positive predictive value PPV and negative predictive value NPV of the Naadi examination in diagnosing participants with Pulmonary pathology
To determine the positive likelihood ratio and negative likelihood ratio of the Naadi examination in diagnosing participants with Pulmonary pathology
To determine the diagnostic performance of Naadi examination using receiver operating characteristic curve analysis and area under the curve
To document the Yakkai Ilakkanam for the participants with Pulmonary pathology through validated questionnaires
STUDY TYPE
Observational Study
STUDY DESIGN
A Prospective Blinded Diagnostic Study
STUDY SETTING
Outpatient and Inpatient department
Ayothidoss Pandithar Hospital
National Institute of Siddha
Chennai 600047
STUDY TIMELINE 18 months
SAMPLE SIZE 348
NUMBER OF CASES 116
NUMBER OF CONTROLS 232
PRIMARY OUTCOME Specificity and Sensitivity of Naadi examination for the diagnosis of cases with Pulmonary pathology will be determined
SECONDARY OUTCOME
Positive Predictive Value PPV and Negative Predictive Value NPV of Naadi examination for participants with Pulmonary pathology will be estimated
Positive Likelihood Ratio and Negative Likelihood Ratio of Naadi examination for participants with Pulmonary pathology will be calculated
Diagnostic performance of Naadi examination for participants with Pulmonary pathology will be assessed using ROC curve analysis and Area Under the Curve
Yakkai Ilakkanam for participants with Pulmonary pathology will be documented through validated questionnaires
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 35.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants who are diagnosed with Pulmonary pathology such as Bronchial Asthma, COPD, Pulmonary fibrosis/ILD, Pneumonia, Bronchiectasis.
排除标准
- •Participants with Acute respiratory infections (eg.,Acute Bronchitis, Active Pneumonia).
- •History of Cardiac diseases affecting breath (CHF, Ischemic heart disease).
- •Vulnerable group (Pregnant women, children, geriatric and cognitive impaired participants).
研究者
Dr M Harini sri
National Institute of Siddha