| CTRI Number |
CTRI/2026/02/103819 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study of Heart Fitness in Middle Aged People in Relation to Their Body Type |
|
Scientific Title of Study
|
Assessment of Cardiovascular Endurance in Middle Aged Individuals with Special Reference to Deha Prakriti a Cross sectional 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 |
Dr Rutuja Dilip Gurav |
| Designation |
MD Scholar |
| Affiliation |
Dr. D. Y. Patil College of Ayurved And Research Centre, Pimpri, Pune 411018 |
| Address |
Dr D.Y.Patil College of Ayurved and Research Centre, Dr.D.Y.Patil Vidyapeeth Deemed to be University, Sant Tukaram Nagar,Pimpri, Pune MAHARASHTRA
411018 India
Pune
MAHARASHTRA
411018
India |
| Phone |
7498487326 |
| Fax |
|
| Email |
rutujadgurav4598@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dushyant Diliprao Patil |
| Designation |
Associate Professor Department of Kriya Sharir |
| Affiliation |
Dr. D. Y. Patil College of Ayurved And Research Centre, Pimpri, Pune 411018 |
| Address |
Dr D.Y.Patil College of Ayurved and Research Centre, Dr.D.Y.Patil Vidyapeeth Deemed to be University, Sant Tukaram Nagar,Pimpri, Pune MAHARASHTRA
411018 India
Pune
MAHARASHTRA
411018
India |
| Phone |
9970348007 |
| Fax |
|
| Email |
dushyant.patil@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dushyant Diliprao Patil |
| Designation |
Associate Professor Department of Kriya Sharir |
| Affiliation |
Dr. D. Y. Patil College of Ayurved And Research Centre, Pimpri, Pune 411018 |
| Address |
Dr D.Y.Patil College of Ayurved and Research Centre, Dr.D.Y.Patil Vidyapeeth Deemed to be University, Sant Tukaram Nagar,Pimpri, Pune MAHARASHTRA
411018 India
Pune
MAHARASHTRA
411018
India |
| Phone |
9970348007 |
| Fax |
|
| Email |
dushyant.patil@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Rutuja Dilip Gurav |
| Address |
Dr D.Y.Patil College of Ayurved and Research Centre, Dr.D.Y.Patil Vidyapeeth Deemed to be University, Sant Tukaram Nagar,Pimpri, Pune MAHARASHTRA
411018 India |
| Type of Sponsor |
Other [Self] |
|
|
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 Rutuja Dilip Gurav |
Dr. D. Y. Patil Ayurved Hospital and Research Centre, Pimpri Pune |
Dr D.Y.Patil College of Ayurved Research Centre Dr.D.Y.Patil Vidyapeeth Deemed to be University Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA |
7498487326
rutujadgurav4598@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 |
Healthy person without any known cardiac condition |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Willing to participate and provide informed consent |
|
| ExclusionCriteria |
| Details |
Individuals with a history of ischemic heart disease (IHD), congestive heart failure (CHF), or cardiac arrhythmias
Participants diagnosed with asthma, chronic obstructive pulmonary disease (COPD), or bronchitis
Known cases of hypertension (HTN) or diabetes mellitus (DM)
Individuals who are on long-term cardiovascular or respiratory medications. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in cardiovascular endurance among middle aged individuals with reference to Deha Prakriti |
Baseline Assessment were done where Difference in cardiovascular endurance among middle aged individuals with reference to Deha Prakriti was observed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Deha Prakriti in middle aged individuals & Assessment of cardiovascular endurance using Harvard Step Test after that Comparison of endurance parameters among different Prakriti types will be observed . |
Single baseline assessment will be done. In which Assessment of Deha Prakriti in middle aged individuals &
Assessment of cardiovascular endurance using Harvard Step Test will be conducted |
|
|
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)
|
25/02/2026 |
| 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 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
|
Cardiovascular endurance is an important indicator of cardio-respiratory fitness and overall health. Middle age (30–40 years) represents a phase of physiological stability, referred to as Madhyamavastha in Ayurveda. Individual variations in physical endurance during this period may be influenced by Deha Prakriti (body constitution), classified as Vata, Pitta, and Kapha. This cross-sectional observational study aims to assess cardiovascular endurance in healthy middle-aged individuals and evaluate its association with different Deha Prakriti types. A total of 300 healthy male and female participants aged 30–40 years will be enrolled. Prakriti assessment will be performed using a validated questionnaire, following which participants will be categorized into Vata, Pitta, or Kapha dominant groups. Cardiovascular endurance will be assessed using the Harvard Step Test, and a fitness index will be calculated based on post-exercise pulse recovery. The primary outcome measure will be the comparison of cardiovascular endurance scores among different Prakriti groups. The study is expected to identify constitution-specific differences in endurance, which may contribute to individualized lifestyle and preventive health strategies. |