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CTRI Number  CTRI/2024/10/075979 [Registered on: 28/10/2024] Trial Registered Prospectively
Last Modified On: 28/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   PCOS and Its Effects on Body Compassion and Quality of Life 
Scientific Title of Study   Impact of Polycystic Ovary Syndrome on Body Compassion and Quality of Life in Women 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nishtha Agarwal 
Designation  Student 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Clinical Psychology,5th floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8850819274  
Fax    
Email  agarwal.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Ms Aparna Daga 
Designation  Assistant Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Clinical Psychology,5th floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9748655646  
Fax    
Email  daga.aparna@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Nishtha Agarwal 
Designation  Student 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Clinical Psychology,5th floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8850819274  
Fax    
Email  agarwal.mchpmpl2023@learner.manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Hospital, Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka, India 576104 
 
Primary Sponsor  
Name  Nishtha Agarwal 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India 576104 
Type of Sponsor  Other [Self-funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhiram PN  Kasturba Hospital  Room no. 11, 33/ Department of Psychiatry OPD, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, 576104
Udupi
KARNATAKA 		 9481338686

abhiram.pn@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMC and KH Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  · Study group
- Women aged 18 and above
- Women diagnosed with PCOS as per Rotterdam criteria
- Women who have been symptomatic of PCOS for at least a year before the data collection
• Control group
- Women aged 18 and above
- No diagnosis of PCOS
- Studied from the same setting as the study group
 
 
ExclusionCriteria 
Details  • History or comorbidity of any other diagnosed psychiatric illness or psychiatric treatment or structured psychological intervention
• History or comorbidity of medical illness
• Patients primarily being treated for infertility
• Pregnant women
• Diabetes
• Obesity
• Untreated hypothyroidism
• Physical disabilities or deformities
• Dermatological conditions
• Alopecia 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Quality of Life  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="298"
Sample Size from India="298" 
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)   04/11/2024 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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   The title of the study is ’Impact of Polycystic Ovary Syndrome on Body Compassion and Quality of Life in Women’. It is a quantitative cross-sectional observational study. It aims to study the effect of PCOS on body compassion and quality of life in women. The study will also compare the correlation of body compassion and quality of life in women with and without PCOS. There is a prominent lack of literature about body compassion, its role in women, specifically women with PCOS. The influence of body compassion on other aspects of life other than health related has not been studied. There is no literature to establish a link between body compassion and quality of life among women, with specific reference to PCOS, too. Sufficient literature is not present to highlight comparative results in women affected and not affected by PCOS. Therefore, this research aims to address the aforementioned gaps and contribute to the current literature by studying body compassion and quality of life in women with as well as without PCOS. 
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