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Comparison of Metformin vs Myoinositol effects on Clinical and Metabolic parameters in PCOS patients

Efficacy and Safety of Metformin versus Myoinositol in improving Clinicometabolic profile in patients diagnosed with Polycystic Ovary syndrome: A Randomized Controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/107521
Enrollment
126
Registered
2026-04-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E282- Polycystic ovarian syndrome

Interventions

Intervention1: Myoinositol: Group 1(Intervention) Drug- Myoinositol Dose- 1 gm Route- Per oral Frequency- Twice daily Duration- For 24 weeks Control Intervention1: Metformin: Group 2(Comparator) Drug-

Sponsors

Dr. Priya Kumari
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
To compare changes in HOMA-IR score following treatment with myo-inositol and metformin at 12 Weeks Timepoint: 12 Weeks

Secondary

MeasureTime frame
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 Timepoint: 12 weeks and 24 weeks

Countries

India

Contacts

Public ContactDr Sangam Jha

AIIMS Patna

sangam.jha78@gmail.com9827388001

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026