| CTRI Number |
CTRI/2025/10/095945 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation Of Sedentary Life On Readings Of Ankle Brachial Index In Students |
|
Scientific Title of Study
|
Association Of Sedentary Lifestyle And Ankle Brachial Index (ABI) In Students |
| 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 Mrudula Mahesh Swami |
| Designation |
PG Scholar |
| Affiliation |
Dr D Y Patil College Of Ayurved And Research Centre Pimpri Pune Maharashtra |
| Address |
Fourth Floor Rachana Sharir Department Dr D Y Patil College Of Ayurved and Research Centre Pimpri Pune
Dr D Y Patil Vidyapeeth Deemed to be University Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7620085030 |
| Fax |
|
| Email |
mrudulaswami@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Damodar Kutte |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil College Of Ayurved And Research Centre Pimpri Pune Maharashtra |
| Address |
Fourth Floor Rachana Sharir Department Dr D Y Patil College Of Ayurved and Research Centre Pimpri Pune
Dr D Y Patil Vidyapeeth Deemed to be University Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9403984664 |
| Fax |
|
| Email |
yogesh.kutte@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh Damodar Kutte |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil College Of Ayurved And Research Centre Pimpri Pune Maharashtra |
| Address |
Fourth Floor Rachana Sharir Department Dr D Y Patil College Of Ayurved and Research Centre Pimpri Pune
Dr D Y Patil Vidyapeeth Deemed to be University Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9403984664 |
| Fax |
|
| Email |
yogesh.kutte@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College Of Ayurved and Research Centre Pimpri Pune 411018 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Mrudula Swami |
Dr D Y Patil College Of Ayurved and Research Centre Pimpri and Dr D Y Patil Vidyapeeth Pimpri Pune |
Fourth Floor Classroom No 6 Dr D Y Patil College Rd Sant Tukaram Nagar Pimpri colony Pimpri Chinchwad Pune
Pune
MAHARASHTRA |
7620085030
mrudulaswami@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr DYPCARC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Population male and female of age 18 to 30 year |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
students having more than 6 hours of physical inactivity |
|
| ExclusionCriteria |
| Details |
subject suffering from known peripheral arterial disease, subject having any congenital heart diseases, subjects doing exercise regularly |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will establish association of sedentary life with Ankle Brachial Index in students |
Only one time observations will be taken |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out sedentary hours in students |
Only once |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/10/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Association of sedentary lifestyle and ankle brachial index in students, this study is a cross sectional observational study where sedentary hours of each student (120 sample size) and reading of ankle brachial index will be measured and possible association will be found out This association will be helpful for predicting peripheral arterial diseases in future |