| CTRI Number |
CTRI/2022/07/043824 [Registered on: 07/07/2022] Trial Registered Prospectively |
| Last Modified On: |
30/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Analytical |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A Study on Cardiac efficiency in different Deha Prakriti. |
|
Scientific Title of Study
|
An analytical study on association between Deha Prakriti and Cardiac efficiency |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
dr priyanka kumari |
| Designation |
m d scholar |
| Affiliation |
National Institute of Ayurveda , Jaipur |
| Address |
Department of Kriya Sharir National Institute of Ayurveda Deemed to be university Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9799784223 |
| Fax |
|
| Email |
priyankaloyal09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr Sarika Yadav |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda Deemed to be university Jaipur |
| Address |
Department of Kriya Sharir National Institute of Ayurveda Deemed to be university Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9467451607 |
| Fax |
|
| Email |
ysarika19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr priyanka kumari |
| Designation |
m d scholar |
| Affiliation |
National Institute of Ayurveda,Jaipur |
| Address |
Department of Kriya Sharir National Institute of Ayurveda Deemed to be university Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9799784223 |
| Fax |
|
| Email |
priyankaloyal09@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of Ayurveda, deemed to be university, Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Deemed to be university Jaipur |
| Address |
Jorawar singh gate, Amer road, Jaipur |
| 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 Priyanka Kumari |
National Institute of Ayurveda,Jaipur |
Department of Kriya Sharir
National Institute of Ayurveda, Jaipur
Jaipur
RAJASTHAN |
9799784223
priyankaloyal09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Assesment of cardiac efficiency in Healthy individuals |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Person of either sex between age group of 18-40 years.
2.Apparently healthy individuals are included.
|
|
| ExclusionCriteria |
| Details |
1.Subjects, who are suffering from cardiac and respiratory abnormalities.
2.Subjects with any addictions or under the influence of any medication.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Association between cardiac efficiency and Deha Prakriti.
|
One and half year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Association between Bala and cardiac efficiency.
|
One and half year |
|
|
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)
|
01/09/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
NEED OF STUDY : Ø As Prakriti is unique constitute which not only determine physical, physiological and psychological behaviour but also aware about chance of occurrence of certain seasonal and systemic disorders. According to Deha Prakriti Acharya Charaka said that individuals of Vata Prakriti has Alpa Bala, individuals of Pitta Prakriti has Madhyam Bala and individuals of Kapha Prakriti has Uttam Bala. Ø Bala can be assessed by using cardiac efficiency test. To understand association between cardiac efficiency with prakriti this study is planned. AIM : To find association between Prakriti and cardiac efficiency. OBJECTIVES : 1. Screening and assessment of Deha Prakriti. 2.Assessment of cardiac efficiency 3.Association of cardiac efficiency with prakriti. STATEMENT OF HYPOTHESIS : Null hypothesis(H0) There is no association between cardiac efficiency and Prakriti. ASSESMENT CRITERIA : Ø Tread mill test Ø Harvard step test For the relevant character of the assessment of Bala, Performa will be developed on the basis of ayurvedic text. |