| CTRI Number |
CTRI/2025/03/081914 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Validation of the Nadi Pulse Instrument (Pulse Testing Tool) |
|
Scientific Title of Study
|
Validation of the nadi pulse instrument (pulse assessment equipment) |
| 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 Rupashri Nath |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Ayurveda, New Delhi |
| Address |
Room No. 306, 3rd Floor, Academic Block, Department Of Roga Nidana Evum Vikriti Vigyana, All India Institute Of Ayurveda, Gautam Puri, Sarita Vihar, New Delhi-110076
South DELHI 110076 India |
| Phone |
6398552356 |
| Fax |
|
| Email |
rupashrinadi.24@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rupashri Nath |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Ayurveda, New Delhi |
| Address |
Room No. 306, 3rd Floor, Academic Block, Department Of Roga Nidana Evum Vikriti Vigyana, All India Institute Of Ayurveda, Gautam Puri, Sarita Vihar, New Delhi-110076
DELHI 110076 India |
| Phone |
6398552356 |
| Fax |
|
| Email |
rupashrinadi.24@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shalini Rai |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Ayurveda, New Delhi |
| Address |
Room No. 306, 3rd Floor, Academic Block, Department Of Roga Nidana Evum Vikriti Vigyana, All India Institute Of Ayurveda, Gautam Puri, Sarita Vihar, New Delhi-110076
South DELHI 110076 India |
| Phone |
9389423843 |
| Fax |
|
| Email |
vd.raishalini@gmail.com |
|
|
Source of Monetary or Material Support
|
| START-UP (NADI PULSE)
All India Institute of Ayurveda, Gautam Puri, Sarita Vihar, Delhi- 110076, India |
|
|
Primary Sponsor
|
| Name |
Startup Nadi Pulse SIIC IITK IIT Kanpur Kanpur Uttar Pradesh |
| Address |
SIIC IITK
IIT Kanpur
Kanpur Uttar Pradesh- 208016 |
| Type of Sponsor |
Other [Private Company] |
|
|
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 Rupashri Nath |
All India Institute Of Ayurveda, New Delhi |
Room No. 306, 3rd Floor, Academic Block, Department Of Roga Nidana Evum Vikriti Vigyana, All India Institute Of Ayurveda, Gautam Puri, Sarita Vihar, New Delhi-110076 South DELHI |
06398552356
rupashrinadi.24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Division of translational research and biostatistics all india institute of ayurveda institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
apparently healthy |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Apparently healthy participants will be selected |
|
| ExclusionCriteria |
| Details |
1. Individuals with known cardiac arrhythmias.
2. Individuals with peripheral vascular diseases affecting pulse palpation.
3. Individuals unable to provide informed consent or cooperate with the assessment.
4. Volunteers with physical disability (Handicapped -no arms)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO ASSESS THE RELIABILITY OF NADI PULSE EQUIPMENT |
1 YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Through rigorous assessment of reliability and validity, this study will provide valuable insights into the effectiveness and accuracy of the Pulse Assessment Tool. The findings will inform its suitability for clinical use and contribute to improving patient care and diagnosis. |
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
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)
|
01/04/2025 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Nadi Pariksha is one among the asta-sthana (eight-fold) examination. Nadi Pariksha is a diagnostic skill, based on the tactile sensitivity of the physicians. elicited by radial artery pulsations. This is an ancient traditional Ayurvedic technique known to Indian physicians since the Vedic era. This is a diagnostic way to assess health status of an individual in terms of dosha levels, to know the untold symptoms, diagnosis and prognosis of disease. The references of the term naadi is found in Charak Samhita. Bhela samhita, Harita samhita, Susruta samhita, Yogashastra and Sidhashastra Sharangadhara Samhita, Yogratnakar, Basavarajiyam texts. This art and knowledge of pulse diagnosis was accepted and practiced in various medical therapies of the world, like in Greek, Chinese, Turkish, Arab, Homeopathy, Allopathic from many years. This diagnostic method has got its significant role in assessment of the physiological and pathological conditions. Naadi pariksha was developed and practiced as a family tradition by naadi vaidyas. This assessment depends on good tactile sensitivity of physician’s fingers. To maintain the secrecy of knowledge, the procedure and the skill remained with the family members of the particular tradition. As this pariksha (examination) is subjective there is difficulty in teaching and learning of this skill. This has led to loss of its wide practise in diagnosis of disease. This knowledge of naadi pariksha is sparsely found and scattered in some of the ayurveda texts. Naadi pariksha requires dedicated concentration, good tactile sensitivity in a physician. Its difficulty in teaching and learning has led to loss of practise in diagnosis of disease. There are various instruments designed for the examination of pulse, but these instruments’ have some lacuna like lack of data capturing methods, some instruments do not follow the classical Ayurveda method, some other instruments study the heartrate variability. This study, efforts to validate an objective diagnostic tool named as Nadipulse. |