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CTRI Number  CTRI/2026/04/107521 [Registered on: 02/04/2026] Trial Registered Prospectively
Last Modified On: 26/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Metformin vs Myoinositol effects on Clinical and Metabolic parameters in PCOS patients  
Scientific Title of Study   Efficacy and Safety of Metformin versus Myoinositol in improving Clinicometabolic profile in patients 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  Dr Priya Kumari 
Designation  Academic Junior Resident 
Affiliation  AIIMS Patna 
Address  Obstetrics and Gynaecology Department,AIIMS Patna,Phulwarisharif,Pin code- 801507

Patna
BIHAR
801507
India 
Phone  9939133993  
Fax    
Email  priya14645@aiimspatna.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sangam Jha 
Designation  Professor,Dept. of Obstetrics and Gynaecology 
Affiliation  AIIMS Patna 
Address  Obstetrics and Gynaecology Department,AIIMS Patna,Phulwarisharif,Pin code- 801507

Patna
BIHAR
801507
India 
Phone  9827388001  
Fax    
Email  sangam.jha78@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sangam Jha 
Designation  Professor,Dept. of Obstetrics and Gynaecology 
Affiliation  AIIMS Patna 
Address  Obstetrics and Gynaecology Department,AIIMS Patna,Phulwarisharif,Pin code- 801507

Patna
BIHAR
801507
India 
Phone  9827388001  
Fax    
Email  sangam.jha78@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr. Priya Kumari 
Address  Obstetrics and Gynaecology Depar,AIIMS Patna,Phulwarisharif,Pin Code-801507 
Type of Sponsor  Other [Self] 
 
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 Sangam Jha   AIIMS Patna  Bgb ward,Ground floor,IPD,Obstetrics and Gynaecology Department,AIIMS Patna,Phulwarisharif,Bihar,Pin code- 801507
Patna
BIHAR 
9827388001

sangam.jha78@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Patna  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  Metformin  Group 2(Comparator) Drug- Metformin Dose- 500 mg Route- Per oral Frequency- Twice daily for 1 week followed by Thrice daily for 23 weeks 
Intervention  Myoinositol   Group 1(Intervention) Drug- Myoinositol Dose- 1 gm Route- Per oral Frequency- Twice daily Duration- For 24 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Women aged 18-40 years.
2. Diagnosed with PCOS as per Rotterdam criteria
3.Willing to participate and provide written informed consent.
4. Patients not planning to get pregnant in 6 months 
 
ExclusionCriteria 
Details  1. Women with diabetes mellitus, thyroid disorders, or hyperprolactinemia.
2. Use of hormonal therapy, insulin sensitizers, or ovulation-inducing drugs within the last
3 months
3. Patients seeking treatment for infertility
4. Known liver, renal, or cardiovascular disease.
5. Pregnant or lactating women.
6. Hypersensitivity or intolerance to study medications. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare changes in HOMA-IR score following treatment with myo-inositol and metformin at 12 Weeks
 
12 Weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effects of both drugs on
1) changes in HOMA-IR score following treatment with myo-inositol and metformin at 24 Weeks
2) Lipid profile
3) Clinical profile (menstrual cycle, Acne, Hirsutism, BMI, Wrist circumference, Waist circumference)
To compare tolerability and side effects
 
12 weeks and 24 weeks 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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)   22/04/2026 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder affecting women of reproductive age and is frequently associated with insulin resistance, menstrual irregularities, hyperandrogenism, and metabolic abnormalities. Metformin is widely used as an insulin-sensitizing agent for the management of PCOS; however, its use may be limited due to gastrointestinal side effects and poor patient adherence. Myo-inositol, a naturally occurring insulin sensitizer involved in insulin signaling pathways, has emerged as a potential alternative therapy with fewer adverse effects.This study aims to compare the efficacy and safety of myo-inositol and metformin in improving the clinicometabolic profile among women diagnosed with PCOS. The study will be conducted as an open-label randomized controlled trial at AIIMS Patna and will include 126 women aged 18–40 years diagnosed with PCOS according to the Rotterdam criteria. Participants will be randomly allocated in a 1:1 ratio to receive either myo-inositol 1 g twice daily or metformin 500 mg twice daily for one week followed by thrice daily dosing for a total duration of 24 weeks.The primary outcome will be the change in insulin resistance measured by HOMA-IR score at 12 weeks. Secondary outcomes will include changes in HOMA-IR at 24 weeks, lipid profile, body mass index, menstrual cycle regularity, acne, hirsutism, and treatment tolerability. The findings of this study may help determine whether myo-inositol can serve as an effective and safer alternative to metformin for the management of PCOS.


 
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