| CTRI Number |
CTRI/2024/05/066861 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2025 |
| 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
|
| 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)= "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)
|
04/09/2024 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
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. |