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CTRI Number  CTRI/2022/12/048046 [Registered on: 13/12/2022] Trial Registered Prospectively
Last Modified On: 11/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Nutrition]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study of Low Carbohydrate Diet for management of Polycystic Ovarian Syndrome 
Scientific Title of Study   To compare the effectiveness of prescribed low carbohydrate diet versus balanced diet in the management of Polycystic Ovarian Syndrome-A randomised controlled clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saraswati kanase 
Designation  Professor 
Affiliation  Anantrao Kanase Homoeopathic Medical College and Hospital  
Address  Anantrao Kanase Homoeopathic Medical College and Hospital Department obstetrics and gynaecology department room no.204 OPD no.2 room no.106 ,Alephata,Tal Junnar,Dist Pune,Maharashtra 412411

Pune
MAHARASHTRA
412411
India 
Phone  9890812362  
Fax    
Email  sckanase@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anuja Bhalerao 
Designation  Professor 
Affiliation  NKP Salave Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital 
Address  NKP Salave Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital Department obstetrics and gynaecology department 3 rd floor Digdoh Hills Hingana Road Nagpur

Nagpur
MAHARASHTRA
440019
India 
Phone  9823680572  
Fax    
Email  anuja_bhalerao@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Saraswati kanase 
Designation  Professor 
Affiliation  Anantrao Kanase Homoeopathic Medical College and Hospital  
Address  Anantrao Kanase Homoeopathic Medical College and Hospital Department obstetrics and gynaecology room no.204 OPD no.2 room no.106 ,Alephata,Tal Junnar,Dist Pune,Maharashtra 412411

Pune
MAHARASHTRA
412411
India 
Phone  9890812362  
Fax    
Email  sckanase@gmail.com  
 
Source of Monetary or Material Support  
NKP Salave Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital 
 
Primary Sponsor  
Name  Saraswati Kanase 
Address  A 1101,One Nation ,Behind Swaraj Garden Hotel,Pimple Saudagar,Pune 411027 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NKP Salave Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital  Digdoh Hills Hingana Road Nagpur 440019 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrNikhil Kanase  Anantrao Kanase Homoeopathic Medical College and Hospital  OPD no.2 Gynaecology opd room no. 106
Pune
MAHARASHTRA 		 9975122237

drkanasenikhil@gmail.com 
DrYogeshree Kanase  DTH CLINIC  OPD no. 3 Gynaecology OPD
Pune
MAHARASHTRA 		 8830656661

dr.yogeshree@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Anantrao Kanase Homoeopathic Medical College and Hospital and Research Centre  Approved 
DTH Clinic  Approved 
NKP,Salve Institute of Medical Sciences &research center & LMH,Nagpur  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 
Comparator Agent  Balanced Diet   Balanced Diet (ICMR NIN RDA) Carbohydrates 50-60%,Protein 15-25%, Fat 20-30% Twice a day Oral STOP Refined carbohydrates like sugar and refined starches Brisk walking 30 minutes 5 days per week,Resistant training 15 minutes 3 sessions per week For 6 months  
Intervention  Low carbohydrate Diet   Carbohydrates less than 125gm (30%),Protein 20-30%,Fat -50% Twice a day Oral stop refined carbohydrates like sugar and refined starches Brisk walking 30 minutes 5 days per week Resistant training 15 minutes 3 sessions per week For 6 months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Diagnosed cases of Polycystic Ovarian Syndrome.
Polycystic Ovarian Syndrome patients not taking oral contraceptives for > 4 weeks.
Hormone treatment or insulin sensitizing agents >2weeks.
Patients willing to participate in study 
 
ExclusionCriteria 
Details  Patients of PCOS who are pregnant.
Patients of PCOS who are lactating.
Patients with existing psychiatric disorders like depression, schizophrenia, anxiety, obsessive conditions, insomnia.
Patients with Prolactinoma, Hypothyroidism

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Menstrual regularity (an initiation of menses or significant shortening of cycle length where possible 21-35 days menstrual cycle length   21-35 days menstrual cycle length  
 
Secondary Outcome  
Outcome  TimePoints 
Weight loss
Laboratory values -Fasting (12Hr)Insulin,fasting sugar,lipid profile.  
after 12 weeks
after 24 weeks 
 
Target Sample Size   Total Sample Size="320"
Sample Size from India="320" 
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 2 
Date of First Enrollment (India)   15/12/2022 
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="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
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-identification.

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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

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

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sckanase@gmail.com].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2033?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Polycystic Ovarian Syndrome  is  syndrome  of endocrine, metabolic disorder of  reproductive age, .Delay in diagnosis  leads to many complications .Once a patient of PCOS always a patient through out life.Treatment of PCOS is symptomatic  and its  expensive. For menstrual irregularity and infertility with treatment also results doubtful .Menstrual regularity only till oral contraceptives are taken ,for infertility patient of PCOS may not conceive.  with low carbohydrate diet and regular exercise menstrual regularity takes place,Improvement in hyperinsulinemia and hyperandrogenism also conception  takes place .Life style modification is good option of treatment at low cost. So it should be first line of treatment of PCOS. In  India very few  randomised  controlled trials  of low carbohydrate diet .So taken randomised controlled trial of low carbohydrate diet against Balanced diet with patients of PCOS. 
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