| CTRI Number |
CTRI/2021/09/036327 [Registered on: 08/09/2021] Trial Registered Prospectively |
| Last Modified On: |
07/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Knowledge and attitude ] |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of intervention on physiological and biochemical parameters of Polycystic Ovarian syndrome |
|
Scientific Title of Study
|
Effectiveness of Multi Interventional Strategies on physiological and biochemical markers of Polycystic ovarian syndrome (PCOS) among young girls. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Niranjani S |
| Designation |
Assistant Professor |
| Affiliation |
Tagore college of Nursing |
| Address |
Community Health Nursing Department
Tagore College of Nursing
Tagore medical college and hospital
Rathinamangalam
Melkotaiyur post
chennai
Kancheepuram
TAMIL NADU
600127
India |
| Phone |
8489898754 |
| Fax |
|
| Email |
niranmay26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Niranjani S |
| Designation |
Assistant Professor |
| Affiliation |
Tagore college of Nursing |
| Address |
Community Health Nursing Department
Tagore College of Nursing
Tagore medical college and hospital
Rathinamangalam
Melkotaiyur post
chennai
Kancheepuram
TAMIL NADU
600127
India |
| Phone |
8489898754 |
| Fax |
|
| Email |
niranmay26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Niranjani S |
| Designation |
Assistant Professor |
| Affiliation |
Tagore college of Nursing |
| Address |
Community Health Nursing Department
Tagore College of Nursing
Tagore medical college and hospital
Rathinamangalam
Melkotaiyur post
chennai
Kancheepuram
TAMIL NADU
600127
India |
| Phone |
8489898754 |
| Fax |
|
| Email |
niranmay26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tagore group of institutions |
|
|
Primary Sponsor
|
| Name |
Niranjani S |
| Address |
F3 Sri sai flats
Sri sai avenue
Nemilicherry
Chrompet
Chennai |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Bhuvaneshwari |
Tagore group of institutions |
Tagore College of Nursing
Tagore Medical college and hospital
Rathinamangalam
chennai 127
Kancheepuram
TAMIL NADU |
9043872624
bhuvana.prabha1981@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,Tagore medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Polycystic ovarian syndrome |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Home management of PCOS |
| Intervention |
Multi interventional strategies |
Cinnamon,exercise and anxiety reduction counseling for 6 months duration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
21.00 Year(s) |
| Gender |
Female |
| Details |
Young girls with PCOS
Who are studying in Tagore group of institutions
Who are willing to participate |
|
| ExclusionCriteria |
| Details |
Who are under PCOS treatment
Who has other health issues |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant reduction in the physiological and biochemical parameters among young girls with PCOs |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall PCOS symptoms |
2 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
10/09/2021 |
| 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 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)?
Response - NO
|
|
Brief Summary
|
The study is to assess the effectiveness of multi interventional strategies on physiological and biochemical parameters of Polycystic ovarian syndrome among young girls at selected colleges. Interventions like cinnamon tea,exercise and anxiety reduction counseling are to be administered for the samples and the effectiveness is measured by the physiological(BMI,waist hip ratio and BP)and biochemical parameters(Total testerone,lipid profile and GTT). |