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CTRI Number  CTRI/2024/04/065564 [Registered on: 12/04/2024] Trial Registered Prospectively
Last Modified On: 10/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   effective treatment regime for PCOS 
Scientific Title of Study   Effectiveness of non hormonal treatment for the management of obese PCOS patients compared to the standard treatment. 
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 Rama Walia 
Designation  Professor 
Affiliation  PGIMER ( post graduate institute of medical education and research ) 
Address  Deptt of Endocrinology ,ground floor, Nehru hospital extension PGIMER ( Post Graduate Institute of Medical Education and Research )Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9872997438  
Fax    
Email  ramawaliapgimer@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rama Walia 
Designation  Professor 
Affiliation  PGIMER ( post graduate institute of medical education and research ) 
Address  Deptt of Endocrinology ,ground floor, Nehru hospital extension PGIMER( post graduate institute of medical education and research )Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9872997438  
Fax    
Email  ramawaliapgimer@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr amal shaharyar 
Designation  senior resident 
Affiliation  PGIMER ( post graduate institute of medical education and research) 
Address  Deptt of Endocrinology ,ground floor, Nehru hospital extension PGIMER ( post graduate institute of medical education and research )Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8475956745  
Fax    
Email  amalshaharyar1689@gmail.com  
 
Source of Monetary or Material Support  
Endocrine society of India, unit no 103 , first floor, sai Datta arcade,himayat nagar, Hyderabad,telangana.500029.  
 
Primary Sponsor  
Name  PGIMER post graduate institute of medical education and research 
Address  PGIMER ( post graduate institute of medical education and research), sector 12, Chandigarh ,160012. 
Type of Sponsor  Government medical college 
 
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 
drrama walia  PGIMER ( post graduate institute of medical education and research)  Deptt of endocrinology , ground floor, Nehru hospital extension,PGIMER Chandigarh
Chandigarh
CHANDIGARH 		 9872997438

ramawaliapgimer@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PGIMER 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  lifestyle modification group semaglutiude group   lifestyle modification group will be given a diet of 1000 to 1200 kcal along with yoga plus cyclical spironolactone ( 25 to 200 mg OD on day 5 to day 25 of menstrual cycle ) and dutasteride ( 0.5 mg OD), given for 9 months. In semaglutide arm tablet semaglutide will be given 3mg to 14 mg OD BBF with cyclical spironolactone and dutasteride in same doses as in lifestyle modification group, given for 9 months. These two group will be compared with OCP given for 21 days and daily spironolactone ( 25 mg to 200mg OD) for 9 months. 
Comparator Agent  OCP and spironolactone  OCP is given from day1 to day21 of menstrual cycle and daily spironolactone 25mg to 200mg daily for 9 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  3 arms are there for PCOS treatment. arm 1 being given drugs with lifestyle modification , arm 2 being given only drugs and arm 3 being given standard treatment with OCPs. 
 
ExclusionCriteria 
Details  age less than 18 years and more than 40 years female
type 2 DM
malignancy
acute infection
chronic infection
pregnant 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
percentage reduction in body weight
free androgen index 		 at 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
menstrual irregularities
hirsutism
BMI
HOMA IR
Lipid profile
glucose tolerance
HRPQCT
hormonal profile- LH FSH PRL Testosterone Estradiol SHBG DHEAS Cortisol AMH
ovarian volume
PCOS QOL 		 1 year 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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   Phase 3 
Date of First Enrollment (India)   12/03/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 17-01-2024 and end date provided 16-01-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   this trial is aimed for treating PCOS patients targeting the pathophysiology of disease and not just providing symptomatic treatment.here we have taken 3 arms of intervention. arm1 is intensive lifestyle modification along with metformin and anti androgens. arm 2 is semaglutide , metformin and anti androgens and arm 3 is oral contraceptive pills with spironolactone. we will be assessing reduction in body weight and free androgen index reduction as primary objectives. 
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