| CTRI Number |
CTRI/2024/09/073329 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Search for ovary related menstrual abnormalities and reasons for that at community |
|
Scientific Title of Study
|
Screening for Polycystic Ovarian Syndrome and its risk factors- A Community based study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sucharitha S |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, MAHE, Manipal. |
| Address |
Department of Community Medicine, 3rd floor, Biochemistry Building, Tiger Circle, Madhav Nagar, Eshwar Nagar Kasturba Medical College, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9972081810 |
| Fax |
|
| Email |
sucharitha.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Veena G Kamath |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of Community Medicine, Tiger Circle, Madhav Nagar, Eshwar Nagar, Kasturba Medical College, MAHE, Manipal
Department of Community Medicine, Tiger Circle, Madhav Nagar, Eshwar Nagar, Kasturba Medical College, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845304647 |
| Fax |
|
| Email |
veenak@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sucharitha S |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of Community Medicine, Tiger Circle, Madhav Nagar, Eshwar Nagar, Kasturba Medical College, MAHE, Manipal
Department of Community Medicine, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Kasturba Medical College, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9972081810 |
| Fax |
|
| Email |
sucharitha.kmcmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Post Graduate Grant, Kasturba Medical College, MAHE, Manipal, Karnataka, India-576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of Community Medicine, Kasturba Medical College, MAHE, Manipal. |
| Type of Sponsor |
Private 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 Sucharitha S |
Kasturba Medical College, MAHE |
Department of Community Medicine, Kasturba Medical College, MAHE, Third floor, Biochemistry building, Tiger circle road, Madhav Nagar, Eshwar Nagar, Manipal-576104
Udupi
KARNATAKA |
9972081810
sucharitha.kmcmpl2023@learner.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 |
Screening for Polycystic ovarian disease |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All eligible women aged 18-40 years who are ready to give consent |
|
| ExclusionCriteria |
| Details |
Pregnant women
Lactating mothers up to 1 year
Women on Hormonal Contraceptives
Houses which remain closed for 2 subsequent visits.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Baseline data will be obtained to determine the risk factors of PCOS among the women of age group 18-40 years |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Data of risk factors associated with PCOS among the women of age group 18-40 years will be obtained. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="1517"
Sample Size from India="1517"
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)
|
19/09/2024 |
| 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)
|
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
|
A pre-designed semi structured questionnaire will be administered to each participant to gather data on their Socio demographic data, family history, Obstetric history, menstrual history, stress assessment, Hirsutism and acne, sleep quality. Socio economic status will be assessed using Modified BG Prasad Scale 2023. Lifestyle factors such as dietary habits will be assessed using Food Frequency questionnaire. Physical activity will be scored according to a survey questionnaire used by Ramachandran A et al. According to the scores obtained, physical activity will be graded as Sedentary (score 1-17), Light (score 18-34), Moderate (score 35-51) and Heavy Physical activity (score >51)(6). Stress will be assessed using DASS 21 stress scale. Anthropometric measurements (Height, Weight, Waist circumference) will be measured as per standard WHO protocol. Blood Pressure (BP) will be recorded using a digital sphygmomanometer and classified as per JNC-8 classification. Random Blood Sugar (RBS) will be measured using a glucometer.
Data will be entered and analysed using JAMOVI. Categorical variables will be presented in the form of percentage/proportions and continuous variable will be presented as mean or median. Chi square test will be used to study association of categorical variables. Multiple logistic regression will be used to identify the risk factors associated with PCOS. |