| CTRI Number |
CTRI/2024/09/073460 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate the prevalence of occupational stress among Panyajeevi W.S.R to bankers in Udupi. |
|
Scientific Title of Study
|
A cross sectional study to evaluate the prevalence of occupational stress among Panyajeevi W.S.R to bankers in Udupi. |
| 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 Jelin George |
| Designation |
PG Scholar |
| Affiliation |
SDM college of Ayurveda and hospitals |
| Address |
Department Of Swasthavritta
SDM College of Ayurveda and Hospitals, Kuthpady, Udupi
Karnataka
Udupi
KARNATAKA
574118
India |
| Phone |
9495672203 |
| Fax |
|
| Email |
jelingeorge04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogeesha Acharya |
| Designation |
Associate Professor |
| Affiliation |
SDM college of Ayurveda and hospitals |
| Address |
Department Of Swasthavritta
SDM College of Ayurveda and Hospitals, Kuthpady, Udupi
Karnataka
Udupi
KARNATAKA
574118
India |
| Phone |
9886055775 |
| Fax |
|
| Email |
yogeeshadr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jelin George |
| Designation |
PG Scholar |
| Affiliation |
SDM college of Ayurveda and hospitals |
| Address |
Department Of Swasthavritta
SDM College of Ayurveda and Hospitals, Kuthpady, Udupi
Karnataka
Udupi
KARNATAKA
574118
India |
| Phone |
9495672203 |
| Fax |
|
| Email |
jelingeorge04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Kuthpady, Udupi 574118
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Jelin George |
| Address |
PG Scholar
Department Of PG Studies of Swasthavritta
SDM College of Ayurveda and Hospitals Kuthpady Udupi 574118 Karnataka 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 Jelin George |
SDM College of Ayurveda and Hospitals Udupi |
OPD and IPD of SDM College of Ayurveda and Hospitals
Kuthpady Udupi 574118
Karnataka
Udupi
KARNATAKA |
9495672203
jelingeorge04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL CLEARANCE COMMITTEE- HUMAN Managed by SHRI DHARMASTHALA MANJUNATHESHWARA EDUCATIONAL SOCIETY UJIRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Bankers in Udupi
age ranging 22 to 60 years completed for at least 2 years in banking sector
with minimum 6 hours of desk job
who is willing to give informed written consent
|
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Bankers in Udupi of age ranging 22 to 60 years 2.completed for at least 2 years in banking sector 3.with minimum 6 hours of desk job in bank
4.who is willing to give informed written consent |
|
| ExclusionCriteria |
| Details |
1.who are taking medications for anxiety disorders
2.who are taking any medication for psychiatric disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the prevalence of occupational stress among bankers in Udupi city using Occupational stress index scale.
To assess the effect of Vegadharana of Mootra, Pipasa, Kshut, and Akaalabhojana among
Panyajeevi w.s.r to bankers in Udupi.
To provide Health education to aid in those hazards among
400 samples of bankers. |
16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
13/09/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This Cross sectional observational study is to assess the prevalence of Occupational Stress among the group of Panyajeevi W.S.R to Bankers in Udupi on a sample size of 400. This Study is to assess occupational stress among the bankers of the Udupi and to assess the effects of Vegadharana of Mootra, Pipasa, Kshut, and Akaalabhojana in Bankers, who are considered as Panyajeevi category through direct personal interview and questionnaire method. Subjects inclusive of age ranging from 22-60 years who completed for at least 2 years in banking sector with desk job of working hours of minimum 6 hours and who is willing to give informed written consent is to be taken. The Primary outcome measure of Occupational Stress is to be assessed by using Occupational Stress Measurement Scale -Assessment of 46 stress factors using Srivastava and A.P. Singh (1981) and Vegadharana effect by validated pre tested questionnaire. And this study also aimed to provide health education related to the risk factors by Health educational approach in social intervention model via direct personal interview & direct group approach. |