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CTRI Number  CTRI/2026/03/106936 [Registered on: 27/03/2026] Trial Registered Prospectively
Last Modified On: 27/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Emotional Dysregulation and Unhealthy Eating Habits in Women with Polycystic Ovarian Syndrome (PCOS) 
Scientific Title of Study   Emotional Dysregulation and Negative Eating Attitudes in Women with Polycystic Ovarian Disorder: A Cross-Sectional 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  Saanya Rajendra 
Designation  Masters Student  
Affiliation  Manipal College of Health Professions 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of higher Education, Bangalore, Karnataka 560017 India

Bangalore
KARNATAKA
560017
India 
Phone  8296409996  
Fax    
Email  saanya.mhsblr2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Jeeshma Vijin 
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of higher Education, Bangalore, Karnataka Bangalore KARNATAKA 560017 India

Bangalore
KARNATAKA
560017
India 
Phone  8217723829  
Fax    
Email  jeeshma.vijin@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Jeeshma Vijin 
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of higher Education, Bangalore, Karnataka Bangalore KARNATAKA 560017 India

Bangalore
KARNATAKA
560017
India 
Phone  8217723829  
Fax    
Email  jeeshma.vijin@manipal.edu  
 
Source of Monetary or Material Support  
No.98, Rustam Bagh Road, Old Airport Road, Department of Clinical Psychology, Manipal College of Health Professions,Manipal Academy of Higher Education, Bangalore,India 560017  
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal,576104 India  
Type of Sponsor  Research institution and hospital 
 
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 
Saanya Rajendra  Manipal Hospitals, Bangalore  Gynecology Department, Basement 1, 98, HAL Old Airport Rd, Kodihalli, Bengaluru, Karnataka 560017 Bangalore KARNATAKA Bangalore KARNATAKA
Bangalore
KARNATAKA 		 8296409996

saanya.mhsblr2024@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of Manipal Hospitals, Bangalore   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 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Women between the ages of 18 and 45 years with a diagnosis of PCOS. 
 
ExclusionCriteria 
Details  Women with other diagnosed endocrine or psychiatric conditions.
Women who are pregnant. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Difficulties in Emotioanl Regulation Scale (DERS)  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Three Factor Eating QUestionnaire (TFEQ-R18)  At baseline 
 
Target Sample Size   Total Sample Size="93"
Sample Size from India="93" 
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)   27/04/2026 
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="6"
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   Emotional Dysregulation and Negative Eating Habits in Women with Polycystic Ovarian Syndrome (PCOS)
PCOS is a commonly reported endocrine/hormonal disorder in women. The visible manifestations of PCOS, like hirsutism, acne, and weight gain, can lead to negative self-perception and, in some cases, lead to an eating disorder. The hormonal changes experienced in this disorder can also make it difficult for women to manage their emotions well, leading to emotional dysregulation. A relationship between emotional dysregulation and negative eating habits is underexplored in the PCOS population. This study tries to understand the relationship between emotional dysregulation and negative eating habits that are not necessarily considered as eating disorders or symptoms of an eating disorder. Women can develop better emotional regulation and a healthier relationship with eating if there is improved treatment and the implementation of coping strategies that help them manage their emotions and accomplish goals in the face of distress. Hence, this study tries to establish a relationship between emotional dysregulation and negative eating habits in women with PCOS.
 
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