| CTRI Number |
CTRI/2024/06/068520 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of Polycystic ovary syndrome among adolescent girl students |
|
Scientific Title of Study
|
Prevalence of Polycystic ovarian syndrome (PCOS) among adolescent girl students of the Udupi 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 Sahana Shetty |
| Designation |
Professor and Head |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Endocrinology
Kasturba Medical College
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9944745014 |
| Fax |
|
| Email |
sahana.shetty@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avivar Awasthi |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Endocrinology
Kasturba Medical College
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9118292244 |
| Fax |
|
| Email |
awasthi.avivar@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avivar Awasthi |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Endocrinology
Kasturba Medical College
Manipal
KARNATAKA
576104
India |
| Phone |
9118292244 |
| Fax |
|
| Email |
awasthi.avivar@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Foundation, Manipal |
|
|
Primary Sponsor
|
| Name |
Manipal foundation |
| Address |
Manipal foundation, Manipal |
| Type of Sponsor |
Other [Trust] |
|
|
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 Sahana Shetty |
Manipal Academy of Higher Education |
Room no 1, Department of Endocrinology
Kasturba Hospital
Manipal
Udupi
KARNATAKA |
9944745014
sahana.shetty@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
To find prevalence of PCOS in adolescent girls |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Female |
| Details |
School girls of reproductive age, who had regular or irregular periods |
|
| ExclusionCriteria |
| Details |
those who are not willing to provide informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of PCOS questionnaire outcome which includes menstrual irregularities and symptoms, demographic data (age, address, BMI, waist circumference) medication history and clinical history (history of diabetes and family history of diabetes and PCOS). |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
17/06/2024 |
| 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="2"
Months="0"
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
|
PCOS awareness and prevalence among young women is quite poor, particularly in rural areas. To prevent long-term consequences like other metabolic disorders and infertility which is a major problem in India, it is very important to conduct screening in community or school for early diagnosis and to create awareness. Given the great diversity of India’s population, community/school -based research are required to shed light on the true prevalence of this condition. PCOS awareness and prevalence among young women is quite poor, particularly in rural areas. To prevent long-term consequences like other metabolic disorders and infertility which is a major problem in India, it is very important to conduct screening in community or school for early diagnosis and to create awareness. Given the great diversity of India’s population, community/school -based research are required to shed light on the true prevalence of this condition. This study involves the evaluation of PCOS questionnaire in order to find the prevalence of PCOS among school girls of Udupi District.
|