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CTRI Number  CTRI/2026/03/106771 [Registered on: 23/03/2026] Trial Registered Prospectively
Last Modified On: 20/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Diagnostic Study 
Study Design  Other 
Public Title of Study   Naadi examination in detecting patients with neck pain. 
Scientific Title of Study   Sensitivity and Specificity of Naadi (Siddha Pulse) Examination in Detecting Individuals with Cervical Spondylopathy attending National Institute of Siddha - A Blinded 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 B Sanju Vikashini 
Designation  Postgraduate Scholar 
Affiliation  National Institute of Siddha 
Address  Room no 20/21, Department of Noi Naadal, Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium, Chennai-47.

Chennai
TAMIL NADU
600047
India 
Phone  7010620524  
Fax    
Email  sanjuvikashinib@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr G J Christian 
Designation  Head of the Department 
Affiliation  National Institute of Siddha 
Address  OP room no 20/21, Noi Naadal Department, National Institute of Siddha, Tambaram Sanatorium, Chennai-600047.

Chennai
TAMIL NADU
600047
India 
Phone  9962545930  
Fax    
Email  christianvijila@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr G J Christian 
Designation  Head of the Department 
Affiliation  National Institute of Siddha 
Address  OP room no 20/21, Noi Naadal Department, National Institute of Siddha, Tambaram Sanatorium, Chennai-600047.

Chennai
TAMIL NADU
600047
India 
Phone  9962545930  
Fax    
Email  christianvijila@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha,Tambaram Sanatorium,Chennai-600047. 
 
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  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr B Sanju Vikashini  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 		 7010620524

sanjuvikashinib@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Siddha  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M472||Other spondylosis with radiculopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Participants who have neck pain and/or upper limb paraesthesia, numbness, or pain for at least 3 months.
Positive responses to any 2 of the following clinical tests: Spurling Test, Lhermitte’s test, Hoffman test, Upper Limb Tension Test, Cervical Distraction Test, and less than 60° of cervical rotation on the impaired side.
Participants with evidence of cervical spondylopathy or other structural abnormality on imaging studies.
 
 
ExclusionCriteria 
Details  Participants presenting with cervical pain showing no evidence of cervical spondylopathy or other structural abnormality on imaging studies.
Vulnerable group (Pregnant and lactating women, children, geriatric and cognitive impaired patients).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Sensitivity and Specificity of Naadi examination for the diagnosis of Cervical spondylopathywill be determined.  Baseline 0th day 
 
Secondary Outcome  
Outcome  TimePoints 
Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of Naadi examination for Cervical spondylopathy will be estimated.  Baseline 0th day 
Pre-test odds and Post-test odds of Cervical spondylopathy based on Naadi examination will be evaluated  Baseline 0th day 
Diagnostic performance of Naadi examination will be assessed using ROC curve analysis and Area Under the Curve (AUC).  Baseline 0th day
 
Different Naadi patterns if observed in different types of Cervical spondylopathy will be documented.  Baseline 0th day 
Positive Likelihood Ratio and Negative Likelihood Ratio of Naadi examination will be calculated.  Baseline 0th day 
Yakkai Ilakkanam for patients with Cervical spondylopathy will be documented through validated questionnaires.  Baseline 0th day 
 
Target Sample Size   Total Sample Size="402"
Sample Size from India="402" 
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)   15/04/2026 
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   The ancient practice of pulse diagnosis has been in existence since antiquity and continues to be used in traditional medical systems such as Unani, Ayurveda, and Chinese medicine. Siddha medicine emphasizes Naadi examination (siddha pulse diagnosis) as a fundamental tool for disease detection and patient assessment.This study aims to determine the accuracy of Naadi in diagnosing cervical spondylopathy, potentially as cost-effective, non-invasive screening tool.

PRIMARY OBJECTIVE:  To determine the sensitivity and specificity of Naadi in detecting the individuals with cervical spondylopathy.

SECONDARY OBJECTIVES:

To determine the positive predictive value (PPV) and negative predictive value (NPV) of the Naadi examination in diagnosing cervical spondylopathy using examination tests and radiological imaging as the reference standard.

To determine the positive likelihood ratio and negative likelihood ratio of the Naadi examination in diagnosing cervical spondylopathy using examination tests and radiological imaging as the reference standard.

To determine the pre-test odds and post-test odds of cervical spondylopathy based on Naadi examination findings, using clinical examination tests and radiological imaging as the reference standard.

To determine the diagnostic performance of Naadi examination using receiver operating characteristic (ROC) curve analysis and area under the curve (AUC).

To estimate difference in Naadi pattern in different types of cervical spondylopathy.

To estimate the yakkai ilakkanam for participants with cervical spondylopathy 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 PERIOD:

18 months.

SAMPLE SIZE: 402

NUMBER OF CASES: 134

NUMBER OF CONTROLS: 268

PRIMARY OUTCOME:

Sensitivity and Specificity of Naadi examination for the diagnosis of Cervical spondylopathywill be determined.

SECONDARY OUTCOMES:

Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of Naadi examination for Cervical spondylopathy will be estimated.

Positive Likelihood Ratio and Negative Likelihood Ratio  of Naadi examination will be calculated.

Pre-test odds and Post-test odds of Cervical spondylopathy based on Naadi examination will be evaluated.

Diagnostic performance of Naadi examination will be assessed using ROC curve analysis and Area Under the Curve (AUC).

 
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