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CTRI Number  CTRI/2025/01/079592 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 21/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [DIET]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to analyse the effectiveness of two types of diets, standard diet and Low Carbohydrate diet in the management of women diagnosed with Polycystic Ovary Syndrome 
Scientific Title of Study   To Analyse the effectiveness of Low carbohydrate diet intervention among women diagnosed with Polycystic Ovary Syndrome A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ArunachalamR 
Designation  Associate Professor 
Affiliation  Government Mohan Kumaramangalam Medical College Hospital, Salem, Tamilnadu, India. 
Address  Department of Anaesthesiology, Government Mohan Kumaramangalam Medical College Hospital, Salem, Tamilnadu, India. PIN 636 001.

Salem
TAMIL NADU
636001
India 
Phone  9965520752  
Fax    
Email  drrarunc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  R Arunachalam  
Designation  Part Time PhD Scholar and Associate Professor 
Affiliation  Government Mohan Kumaramangalam Medical College and Hospital 
Address  Department of Anaesthesiology, Government Mohan Kumaramangalam Medical College Hospital, Salem, Tamilnadu, India. PIN 636 001.

Salem
TAMIL NADU
636001
India 
Phone  9965520752  
Fax    
Email  drrarunc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Brindha R 
Designation  Professor and Head of the Department 
Affiliation  VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS SALEM TAMILNADU 
Address  Department of Anaesthesiology Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinna Seeragapadi Salem

Salem
TAMIL NADU
636308
India 
Phone  9443247021  
Fax    
Email  mskbrins63@gmail.com  
 
Source of Monetary or Material Support  
Government Mohan Kumaramangalam Medical College and Hospital which located in Salem District of the Tamilnadu state will be providing the necessary support for the trial. 
 
Primary Sponsor  
Name  Government Mohan Kumaramangalam Medical College and Hospital 
Address  Department of Anaesthesiology, Government Mohan Kumaramangalam Medical College and Hospital, Salem, Tamilnadu, India. PIN 636 001.  
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 
Dr ARUNACHALAM R  Government Mohan Kumaramangalam Medical College and Hospital  Diet clinic, Gynaecology Unit - Outpatient Department, Government Mohan Kumaramangalam Medical College Hospital, Salem, Tamilnadu, India. PIN 636 001.
Salem
TAMIL NADU 		 9965520752

drrarunc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE OF Government Mohan Kumaramangalam Medical College Hospital, Salem, Tamilnadu, India.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Low Carbohydrate Diet  The intervention group will be counselled to eat a low carbohydrate diet daily with composition as suggested by an expert panel for a period of maximum 6 months. 
Comparator Agent  Standard South Indian Diet   The control group will be asked to consume standard south Indian diet daily and will be given medications and treatments usually prescribed for the PCOS condition for a period of maximum of 6 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Women in the age group 18-45 years of age diagnosed with PCOS as per Rotterdam Criteria
Attending the outpatient clinic during the study period
 
 
ExclusionCriteria 
Details  Diabetes Mellitus
Chronic Hypertension
Cardiovascular Diseases
Endometriosis
Patients on drugs which affect the observation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary Outcomes will be Change in the weight and BMI
and Regularity of menstrual cycles (Assessed by Self Reported Charting)

 		 3 to 6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
SECONDARY OUTCOMES will be Changes in Glycaemic control parameters including Fasting Blood Sugars & Glycated Haemoglobin (HbA1C), Changes in serum lipid profile (Total Cholesterol, Serum Triglycerides, Low Density Lipoproteins, Very Low Density Lipoproteins & High Density Lipoproteins levels), Changes in Insulin resistance parameters, Changes in Liver Function Tests, Changes in ovarian morphology as assessed by Ultrasonography, Changes in androgenic features of PCOS including facial hair growth & Fertility outcomes among married women & those who are anxious to conceive
 		 3 to 6 months 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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)   01/02/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

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

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

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  DEIDENTIFIED ANONYMISED DATA IN EXCEL SHEET

  6. For how long will this data be available start date provided 08-01-2025 and end date provided 08-01-2027?
    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 will be a randomized controlled trial to analyse the effectiveness of Low Carbohydrate diet in comparison with Standard South Indian Diet in the management of women in the age group of 18-45 years of age with Polycystic Ovary Syndrome. The composition of Low Carbohydrate Diet will be as per the recommendations of an expert panel set up specifically to recommend a suitable diet. The Primary outcomes will be change in weight and regulation of menstrual cycles indicating resumption of normal ovulation. Secondary outcomes will look at improvement in metabolic and hormonal parameters and fertility parameters in those who are anxious to conceive.

 
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