| 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
|
|
|
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
|
|
|
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
|
|
|
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.
|