| CTRI Number |
CTRI/2026/03/107018 [Registered on: 30/03/2026] Trial Registered Prospectively |
| Last Modified On: |
19/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
DIAGNOSTIC STUDY |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the Role of Siddha Pulse (Naadi) Diagnosis in identifying Lung Disorders at National Institute of Siddha |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Harini sri |
| Designation |
Postgraduate Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Teaching Block 2 Department of Noi Naadal National Institute of Siddha Tambaram Sanatorium Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
7708116260 |
| Fax |
|
| Email |
harinisri2552@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Ramamurthy |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Teaching Block 2 Department of Noi Naadal National Institute of Siddha Tambaram Sanatorium Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
8667819495 |
| Fax |
|
| Email |
ramsnis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Ramamurthy |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Teaching Block 2 Department of Noi Naadal National Institute of Siddha Tambaram Sanatorium Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
8667819495 |
| Fax |
|
| Email |
ramsnis@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandithar Hospital National Institute of Siddha Tambaram Sanatorium Chennai- 47 |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
National Institute of Siddha Tambaram Sanatorium
Chennai-47 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M Harini Sri |
National Institute of Siddha |
OPD and IPD of Ayothidoss Pandithar Hospital Room No, 20/21 Department of Noi Naadal Tambaram Sanatorium Chennai-47
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
7708116260
harinisri2552@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Siddha, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J984||Other disorders of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Participants who are diagnosed with Pulmonary pathology such as Bronchial Asthma, COPD, Pulmonary fibrosis/ILD, Pneumonia, Bronchiectasis. |
|
| ExclusionCriteria |
| Details |
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). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Specificity and sensitivity of Naadi examination for the diagnosis of cases with Pulmonary pathology will be determined at baseline |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Positive Predictive Value PPV and Negative Predictive Value NPV of Naadi examination for participants with Pulmonary pathology will be estimated at baseline.
Positive Likelihood Ratio and Negative Likelihood Ratio of Naadi examination for participants with Pulmonary pathology will be calculated at baseline.
Diagnostic performance of Naadi examination for participants with Pulmonary pathology will be assessed using ROC curve analysis and Area Under the Curve AUC at baseline
Yakkai ilakkanam for participants with Pulmonary pathology will be documented through validated questionnaires at baseline |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="348"
Sample Size from India="348"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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 |