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CTRI Number  CTRI/2018/03/012643 [Registered on: 19/03/2018] Trial Registered Prospectively
Last Modified On: 16/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare Inositol with oral contraceptive pills on menstrual regulation in young girls with PCOS. 
Scientific Title of Study   To study the role of Myo-inositol-D-chiro-inositol Combination Versus Combined Oral Contraceptives on Clinico-hormonal and Metabolic Parameters in Young Asian-Indian Girls with Polycystic Ovary Syndrome 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Garima Kachhawa 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  3086, Teaching Block, AIIMS

New Delhi
DELHI
110029
India 
Phone  01126594941  
Fax    
Email  garimakachhawa2012@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Garima Kachhawa 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  3086, Teaching Block, AIIMS

New Delhi
DELHI
110029
India 
Phone  01126594941  
Fax    
Email  garimakachhawa2012@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Krithika V S 
Designation  Resident 
Affiliation  All India Institute of Medical Sciences 
Address  3086, Teaching Block, AIIMS

New Delhi
DELHI
110029
India 
Phone  09994887983  
Fax    
Email  drkrithi30@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, New Delhi 
 
Primary Sponsor  
Name  Department of Obstetrics Gynaecology 
Address  3086, Teaching block, AIIMS, New delhi-110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 Garima Kachhawa  Department of Obstetrics and Gynaecology  Room no.3086, 3rd Floor, Teaching block, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI 		 01126594941

garimakachhawa2012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Polycystic Ovary Syndrome (PCOS),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Combined Oral Contraceptive  Combined Oral Contraceptive containing ethinyl estradiol 20 mcg and drospirenone 3 mg from day 1 of menstrual cycle for 6 cycles. 
Intervention  Myo-inositol-D-chiro-inositol  Myo-inositol 550 mg + D-chiro-inositol 150 mg BD for 6 months 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  24.00 Year(s)
Gender  Female 
Details  1) Young girls in the age-group of 15-24 years (or atleast 2 years after the onset of menarche) with PCOS diagnosed by two out of the following criteria
a) Hyperandrogenism - Clinical(hirsutism
diagnosed by modified Ferriman -Gallwey
score more than or equal to 8/36) or
Biochemical (serum testosterone >0.5 ng/L)
b) Persistent oligo/anovulation characterized
by irregular menstrual cycles (19-90 days)
or absent menstrual cycles ( for a period
equivalent to previous 3 menstrual cycles)
c) Polycystic ovaries on ultrasound diagnosed
when ovarian volume more than 10 cu.cm.
d) Insulin resistance
2) Patients who are willing to give consent for
the study and willing for follow-up.
 
 
ExclusionCriteria 
Details  1) Pregnancy.
2) A known case of diabetes mellitus.
3) Patients who are taking or had taken any
hormonal treatment including contraceptives
over the past 3 months.
4) Patients who are taking or who had used
glucocorticoids, lipid-lowering drugs,
glucose-lowering drugs or anti-obesity drugs
within 3 months of the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Menstrual cycle length
expressed as average of
days between cycles.
2.Modified Ferriman- Gallwey
score and Acne scoring
 		 6 months and 3 months after stopping treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Ovarian volume–lxbxw (cc)
2.Change in Serum AMH, FSH,
LH, Testosterone
3.Changes in blood sugar
profile, lipid profile
4.Homeostatic Model
Assessment (HOMA-IR)
5.Compliance
6.Body Weight

 		 6 months and 3 months after stopping treatment 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   23/03/2018 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Polysystic Ovary Syndrome (PCOS) is the most common endocrine cause of menstrual irregularity, hyper androgenism and infertility. In young girls, menstrual irregularity creates anxiety and traditionally combined oral contraceptives(COC) form the first line of management. But, COCs are associated with wide range of side effects and prescribing contraceptives to young girls creates anxiety among parents. This open labelled randomized clinical study aims to compare the efficacy of nutritional supplements Myo-Inositol-D-Chiro-Inositol Combination versus Combined Oral Contraceptives on Clinico-hormonal and Metabolic Parameters in 70 young girls with PCOS. The primary outcome measures will be regularization of menstrual cycles and effect on acne and hirsutism.

 
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