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CTRI Number  CTRI/2024/04/066008 [Registered on: 19/04/2024] Trial Registered Prospectively
Last Modified On: 13/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   DIAGNOSTIC STUDY 
Study Design  Other 
Public Title of Study   A study to examine Naadi (pulse) in Hypertension patients 
Scientific Title of Study   Analysis of Siddha Naadi (pulse) examination in Hypertension – 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  D KRISHNAAVENI  
Designation  PG SCHOLAR 
Affiliation  NATIONAL INSTITUTE OF SIDDHA 
Address  Department of Noi Naadal, Room No: 20,21 Ayithidoss Pandithar Hospital, National Institute Of Siddha, Tambaram Sanatorium, Chennai-600047.

Chennai
TAMIL NADU
600047
India 
Phone  9445319654  
Fax    
Email  drkrishveni87@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M Ramamurthy 
Designation  Associate Professor 
Affiliation  NATIONAL INSTITUTE OF SIDDHA 
Address  Department of Noi Naadal, Room No: 20,21 Ayothidoss Pandithar Hospital, National Institute Of Siddha, Tambaram Sanatorium, Chennai-600047.

Chennai
TAMIL NADU
600047
India 
Phone  9443178112  
Fax    
Email  ramsnis@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M Ramamurthy 
Designation  Associate Professor 
Affiliation  NATIONAL INSTITUTE OF SIDDHA 
Address  Department of Noi Naadal, Room No: 20,21, Ayothidoss Pandithar Hospital, National Institute Of Siddha, Tambaram Sanatorium, Chennai-600047.

Chennai
TAMIL NADU
600047
India 
Phone  9443178112  
Fax    
Email  ramsnis@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Siddha, Tambaram Sanatorium, Chennai-600047, Tamilnadu. 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Not applicable ] 
 
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 D KRISHNAAVENI   NATIONAL INSTITUTE OF SIDDHA  Department of Noi Naadal, Room no 20/21, Ayothidoss Pandithar Hospital, Tambaram Sanatorium, Chennai-600047, Tamilnadu.
Chennai
TAMIL NADU 		 9445319654

drkrishveni87@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: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age: 20-60
Sex: Male, Female, Transgender
Patients who are diagnosed with Hypertension as per ASH (American Society of Hypertension) guidelines.
Patients who are willing to sign consent form.
 
 
ExclusionCriteria 
Details  Patients who is not willing to participate in study.
Patients with systemic illness.
Vulnerable group (pregnant 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 
Specificity and Sensitivity of Naadi examination for the diagnosis of Hypertension will be obtained.
 		 BASELINE 0TH DAY
 
 
Secondary Outcome  
Outcome  TimePoints 
Different Naadi patterns if observed in different grades/stages of Hypertension will be documented.
Yakkai Ilakkanam for Hypertensive patients will be documented through validated questionnaires.
 		 BASELINE 0TH DAY 
 
Target Sample Size   Total Sample Size="516"
Sample Size from India="516" 
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)   26/04/2024 
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 is a non-invasive, no instrument, cost effective diagnostic tool which does not require any prior preparation that can be done at any time. This study will determine the usefulness of Naadi as a screening tool in diagnosis of Hypertension.

Primary objective:

·To determine the diagnostic accuracy of Naadi in diagnosing Hypertension.

Secondary objective:

·To document difference in Naadi pattern in different grades/stages of Hypertension.
·To document the Yakkai Ilakkanam for Hypertensive patients through validated questionnaires.

Study type:

Diagnostic study

STUDY DESIGN:

Blinded diagnostic study

Study place:

Outpatient and Inpatient department,

Ayothidoss Pandithar Hospital,

National Institute of Siddha,

Chennai-600047.

Study period:

18 months.

SAMPLE SIZE: 172
HYPERTENSIVE PATIENTS: 172
HEALTHY VOLUNTEERS: 344 

PRIMARY OUTCOME:

Specificity and Sensitivity of Naadi examination for the diagnosis of Hypertension will be obtained.

SECONDARY OUTCOME:

Different Naadi patterns if observed in different grades/stages of Hypertension will be documented.

Yakkai Ilakkanam for Hypertensive patients will be documented through validated questionnaires.

 
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