| CTRI Number |
CTRI/2024/08/072876 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study Of Stress levels along with stress Indicators And comparing them with Metabolic Disease Markers In Working Women Of Ballari District. |
|
Scientific Title of Study
|
A Case Control Study Of Perceived Stress Levels With Its Indicators And Uric Acid/HDL Ratio In Apparently Healthy Working Women In Ballari District. |
| 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 Vijay Venkataiah |
| Designation |
Associate Professor |
| Affiliation |
Ballari Medical College and Research Centre BALLARI |
| Address |
Department of Biochemistry,
Ballari Medical College and Research Centre, Cantonment, Ballari-583104
Bellary
KARNATAKA
583104
India |
| Phone |
9742888245 |
| Fax |
|
| Email |
dr.venkat.vi22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Venkataiah |
| Designation |
Associate Professor |
| Affiliation |
Ballari Medical College and Research Centre BALLARI |
| Address |
Department of Biochemistry
Ballari Medical College and Research Centre, Cantonment, Ballari-583104
Bellary
KARNATAKA
583104
India |
| Phone |
9742888245 |
| Fax |
|
| Email |
dr.venkat.vi22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Venkataiah |
| Designation |
Associate Professor |
| Affiliation |
Ballari Medical College and Research Centre BALLARI |
| Address |
Department of Biochemistry,
Ballari Medical College and Research Centre, Cantonment, Ballari-583104
Bellary
KARNATAKA
583104
India |
| Phone |
9742888245 |
| Fax |
|
| Email |
dr.venkat.vi22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vijayanagar Institute of Medical Sciences, Ballari-583104, kARNATAKA, INDIA |
|
|
Primary Sponsor
|
| Name |
Vijayanagar Institute of Medical Sciences Ballair |
| Address |
Department of Biochemistry, VIMS, Cantonment, Ballari-583104, Karnataka, INDIA |
| 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 Vijay Venkataiah |
MCH Hospital VIMS Ballari |
Central Diagnostic Lab
Department of Biochemistry
VIMS ,ballari -583104
Bellary
KARNATAKA |
9742888245
dr.venkat.vi22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VIMS INSTITUTIONAL ETHICS COMMITTE, BALLARI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently healthy working women with increased perceived stress levels. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Non pregnant women who are working for more than one year are included in the study. |
|
| ExclusionCriteria |
| Details |
Pregnant women and Women with fever, thyroid disorders, and who are taking medicines for psychiatric illness, and who are undergoing any hormonal therapy are excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increased stress in working women can be a risk factor for metabolic disorders. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proper stress management in working women can be a good preventive measure in development of metabolic disorders. |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
05/09/2024 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Working women in India are more prone for psychological stress that increases blood stress markers and inflammatory markers. Chronic increase in these markers can be a risk factor for development of metabolic disorders which can be assessed by measuring Uric acid and HDL ratio. Increased perceived stress can lead to metabolic disorders. |