| CTRI Number |
CTRI/2025/03/082546 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
13/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluate The Efficacy Of Yoga Break Module And Instant Relaxation Technique (Irt) In Occupational Stress In Employees Of National Institute Of Ayurveda Jaipur |
|
Scientific Title of Study
|
A Randomized Comparative Trial To Evaluate The Efficacy Of Yoga Break Module And Instant Relaxation Technique (Irt) In Occupational Stress In Employees Of National Institute Of Ayurveda, Jaipur |
| 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 Virendra Kumar Chhandak |
| Designation |
PG Scholar |
| Affiliation |
National Institute Of Ayurveda Jaipur |
| Address |
Room No. 201 Department Of Swasthavritta Evam Yoga National Institute Of Ayurveda Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
7014996187 |
| Fax |
|
| Email |
vkchhandak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvesh Kumar Agrawal |
| Designation |
Associate Professor |
| Affiliation |
National Institute Of Ayurveda Jaipur |
| Address |
Room No. 228 Department Of Swasthavritta Evam Yoga National Institute Of Ayurveda Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
8058697177 |
| Fax |
|
| Email |
drsarvesh1008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarvesh Kumar Agrawal |
| Designation |
Associate Professor |
| Affiliation |
National Institute Of Ayurveda Jaipur |
| Address |
Room No. 228 Department Of Swasthavritta Evam Yoga National Institute Of Ayurveda Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
8058697177 |
| Fax |
|
| Email |
drsarvesh1008@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
National Institute Of Ayurveda Jaipur |
| Address |
National Institute Of Ayurveda Jorawar Singh Gate Amber Road Jaipur Rajasthan 302002 |
| Type of Sponsor |
Government medical college |
|
|
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 Virendra Kumar Chhandak |
National Institute Of Ayurveda |
National Institute of Ayurveda Jorawar Singh Gate Amber Road
Jaipur
RAJASTHAN |
7014996187
vkchhandak@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 |
| Patients |
(1) ICD-10 Condition:F488||Other specified nonpsychotic mental disorders. Ayurveda Condition: MANOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: N/A, Ritucarya: N/A, Acara Rasayana:N/A, Other:Yoga Break Module for 4 weeks, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: N/A, Ritucarya: N/A, Acara Rasayana:N/A, Other:Instant Relaxation Technique for 3 times in each round, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Employees of NIA Jaipur irrespective of their age and gender
In the Prevalence study the employees having moderate stress on perceived stress scale in the last one month
In the trial study the employees having moderate stress on perceived stress scale in the last one month
|
|
| ExclusionCriteria |
| Details |
Employees contraindicated for Instant Relaxation Technique and Yoga Break
Employees who are already practicing the Yoga Break regularly for 5 minutes 2 times a day and Instant Relaxation Technique for 3 times in each round
Employees taking any sort of tranquilizers anti depressant anti anxiolytic anti psychotic etc drugs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in perceived stress scale score |
0 and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevalence of occupational stress in NIA |
4 Weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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
|
Our Purpose Is to study the effect of Yoga Break Module and Instant Relaxation Technique in Stess in Employees of National Institute of Ayurveda |