| CTRI Number |
CTRI/2024/05/066861 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Study The Association Between Deha Prakriti and Blood pressure Heart rate |
|
Scientific Title of Study
|
A Cross Sectional Study To Find Out Association Between Deha Prakriti And Status Of Cardiovascular Autonomic Functions Of NIA Scholars. |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meenakshi Mourya |
| Designation |
MD scholar |
| Affiliation |
National institute of ayurveda jaipur |
| Address |
236 room no Department of kriya sharir National Institute of Ayurveda jaipur 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9782968433 |
| Fax |
|
| Email |
mouryameenakshi2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarika Yadav |
| Designation |
Assistant professor |
| Affiliation |
National institute of ayurveda jaipur |
| Address |
Department of kriya sharir room no 236 National institute of ayurveda jaipur 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9467451607 |
| Fax |
|
| Email |
ysarika19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarika Yadav |
| Designation |
Assistant professor |
| Affiliation |
National institute of ayurveda jaipur |
| Address |
Department of kriya sharir room no 236 National institute of ayurveda jaipur 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9467451607 |
| Fax |
|
| Email |
ysarika19@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of ayurveda Jaipur near jorawar singh gate Amer road 302002 Rajasthan India |
|
|
Primary Sponsor
|
| Name |
National institute of ayurveda jaipur |
| Address |
National institute of ayurveda jorawar singh gate Jaipur Rajasthan 302002 |
| 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 Meenakshi Mourya |
National Institute of Ayurved Jaipur |
Department of Kriya Sharir Advanced human physiology lab room number 218 National Institute of Ayurveda Jaipur jorawar singh gate 302002 Rajasthan India
Jaipur
RAJASTHAN |
9782968433
mouryameenakshi2@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National institute of ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Persons of either sex between Age 20-30 years |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Apparently healthy scholars of NIADU having Ekdosha Pradhan Prakriti |
|
| ExclusionCriteria |
| Details |
Any individual who are suffering from already diagnosed nervous system disorders.
Any individual with any addictions or under the influence of any medication.
Any individual with history of cardiac pacemaker implantation or angioplasty.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between Deha Prakriti and status of cardiovascular autonomic functions |
18 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevalence of different deha prakriti |
12 Months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/09/2024 |
| Date of Study Completion (India) |
31/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Need of the Study The autonomic nervous system plays a crucial role in the maintenance of homeostasis. Disturbance in this homeostasis may lead to many systemic diseases. Ayurveda has explained unique fundamental principles like Prakriti Agni Mahabhuta Mala etc. Prakriti is one of those principles. Lots of work is already done on Prakriti but pertaining to ANS a vast scope of research is still available to solve the unresolved epistemic uncertainties. There is need to study about the status of cardiovascular autonomic functions and find its possible relationship with Deha Prakriti. A few scattered works are found regarding Deha Prakriti and cardiovascular autonomic functions. Keeping about these points in mind the present study is planned to understand association between Deha Prakriti and status of cardiovascular autonomic functions. Aim To find association between Deha Prakriti and status of cardiovascular autonomic functions. Objective To Assess Deha Prakriti of apparently healthy individuals by using validate proforma of Kriya Sharir Department of NIADU Jaipur To Assess the status of cardiovascular autonomic functions. To study the association between Deha Prakriti and status of cardiovascular autonomic functions. Hypothesis Null hypothesis There is no association between Deha Prakriti and status of cardiovascular autonomic functions. Alternate hypothesis There is association between Deha Prakriti and status of cardiovascular autonomic functions.
OUTCOME Association between Deha Prakriti and status of cardiovascular autonomic functions.
ASSESSMENT CRITERIA Tests for Sympathetic functions Cold pressure response (CRR) Hand grip test (BP response to Isometric) Tests for Parasympathetic functions 1 Standing test (30:15 RR ratio) 2 Standing to lying ratio (SL ratio) 3 Valsalva ratio test 4 Tachycardia ratio 5 Deep breathing test |