| CTRI Number |
CTRI/2020/04/024922 [Registered on: 29/04/2020] Trial Registered Prospectively |
| Last Modified On: |
24/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of Health Related Quality of Life among Reproductive Age Group Women in Poly Cystic Ovarian Syndrome patients-A Cross Sectional Study |
|
Scientific Title of Study
|
Evaluation of Health Related Quality of Life among Reproductive Age Group of Women in Soothaga Vaayu (Poly Cystic Ovarian Syndrome) patients Attending OPD at AAGHIM Chennai-A Cross Sectional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Boomathi S |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College Chennai |
| Address |
Post graduate Department of General Medicine Government Siddha Medical College Arumbakkam Chennai 600106 Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
9095909539 |
| Fax |
- |
| Email |
boomathisozhanambi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chithra S M |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College Chennai |
| Address |
Post graduate Department of General Medicine Government Siddha Medical College Arumbakkam Chennai 600106 Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
9444177230 |
| Fax |
- |
| Email |
chittu758@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Boomathi S |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College Chennai |
| Address |
Post graduate Department of General Medicine Government Siddha Medical College Arumbakkam Chennai 600106 Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
9095909539 |
| Fax |
- |
| Email |
boomathisozhanambi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College Arumbakkam Chennai 600106 Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
Government Siddha Medical College Arumbakkam Chennai 600106 Tamilnadu |
| 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 Boomathi S |
Arignar Anna Government Hospital of Indian Medicine |
op no S1 Department of PG maruthuvam Government Siddha Medical College Arumbakkam Chennai 600106
Chennai
TAMIL NADU |
9095909539
-
boomathisozhanambi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Female patients age between 15 to 35 years attending out patient department at Arignar Anna Govt Hospital of Indian Medicine |
|
| ExclusionCriteria |
| Details |
Age group less than 15 years and above 35 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The present study will evaluate the health related quality of life in soothaga vaayu (poly cystic ovarian syndrome) among reproductive age group of women by HRQL . |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of HRQL will give information about physical and emotional aspect of PCOS patients for giving effective treatment related to them in future clinical trials |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/05/2020 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a cross sectional study to evaluate the health related quality of life among reproductive age group between 15 to 35 years attending out patient department at Arignar Anna Govt Hospital of Indian medicine , Chennai . The questionnaire which consists of 33 questions to assess the symptoms of poly cystic ovarian syndrome. That the results obtained will identify the physical and emotional aspects of the patients affected with poly cystic ovarian syndrome to proceed for an effective treatment |