| CTRI Number |
CTRI/2025/03/082372 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Other (Specify) [Mobile Application] |
| Study Design |
Other |
|
Public Title of Study
|
PCOS Help: A Simple Guide to Managing Your Symptoms |
|
Scientific Title of Study
|
A prospective interventional study- A mobile based application for PCOS |
| 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.Roselin Sheela |
| Designation |
Post graduate |
| Affiliation |
Saveetha medical college and hospita |
| Address |
Obstetrics and Gynecology,Labour room no: 150, Saveetha medical college and hospital, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu, India, pincode : 602105 Obstetrics and Gynecology,Labour room no: 150, Saveetha medical college and hospital, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu, India
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9003133667 |
| Fax |
|
| Email |
roselinsheela20498@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parimala A |
| Designation |
Professor |
| Affiliation |
Saveetha medical college and hospita |
| Address |
Obstetrics and Gynecology,Labour room no: 150, Saveetha medical college and hospital, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu, India, pincode : 602105 Obstetrics and Gynecology,Labour room no: 150, Saveetha medical college and hospital, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu, India
Chennai
TAMIL NADU
602105
India |
| Phone |
9840281506 |
| Fax |
|
| Email |
parimalachats2002@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ROSELIN SHEELA J |
| Designation |
POST GRADUATE |
| Affiliation |
Saveetha medical college and hospita |
| Address |
Obstetrics and Gynecology,Labour room no: 150, Saveetha medical college and hospital, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu, India, pincode : 602105 Obstetrics and Gynecology,Labour room no: 150, Saveetha medical college and hospital, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu, India, pincode : 602105
Chennai
TAMIL NADU
602105
India |
| Phone |
9003133667 |
| Fax |
|
| Email |
roselinsheela20498@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha medical college and hospital
Obstetrics and Gynecology,Labour room no: 150, Saveetha medical college and hospital, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu, India, pincode : 602105 Obstetrics and Gynecology,Labour room no: 150, Saveetha medical college and hospital, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu, India, pincode : 602105 |
|
|
Primary Sponsor
|
| Name |
Saveetha medical college and hospital |
| Address |
Saveetha medical college and hospital
Poonamallee, Poonamallee High Road
Kuthambakkam Chennai 602105 |
| 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 Roselin Sheela |
Saveetha medical college |
Obstetrics and Gynecology,Labour room no: 150, Saveetha medical college and hospital, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu, India, pincode : 602105 Obstetrics and Gynecology,Labour room no: 150, Saveetha medical college and hospital, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu, India, pincode : 602105
Kancheepuram
TAMIL NADU |
9003133667
-
roselinsheela20498@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha medical college- Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PCOS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A mobile based application gives diet and exercise |
Diet and exercise given for 3 momths |
| Comparator Agent |
HrQOL(health related quality of life) effects in patients not using diet and exercise |
Life style modification via application is given, diet for 3 months - to see calories and targeted exercise 30 minutes per day for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
18-45 years
Menstrual disturbances
Diagnosed PCOS ( PCO morphology) |
|
| ExclusionCriteria |
| Details |
Hyperprolactinemia
Major illness affecting quality of life
Linguistic/ cognitive difficulties
Cushing syndrome
Congenital adrenal hyperplasia
Androgen secreting tumours
Hyperthyroidism Hypothyroidism
Hormonal medication
Pregnancy
Lactation
Exposed to ontological treatment |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study goal is to evaluate HRQoL among PCOS patients through a mobile application and detect notable differences in HRQoL after 3 months |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intervention like diet & exercise improves quality of life or not after 3 months |
3 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
12/02/2026 |
| 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="9"
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
|
We are conducting a study to investigate how PCOS affects HRQoL and the role of lifestyle changes. A group of participants diagnosed with PCOS has been recruited. We will analyse the results using a standardised questionnaire to understand the conditions daily impact. By identifying and measuring these aspects the questionnaire will provide valuable insights to improve PCOS management |