A clinical trial to study the effect of myoinositol based therapy in combination with metformin as compared to metformin alone in women with polycystic ovarian syndrome

A Randomized Controlled Trial comparing Myoinositol based therapy in combination with Metformin versus Metformin monotherapy on the clinical, metabolic and hormonal parameters in Obese reproductive age women with Polycystic Ovarian Syndrome

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/03/032468

Enrollment

Registered

2021-03-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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 1.1g with D-Chiroinositol 27.6mg: Tablet Myoinositol 1.1g with D-Chiroinositol 27.6mg twice daily, combined with tablet metformin 500mg twice daily for 3-6months Control Int

Eligibility

Inclusion criteria

Inclusion criteria: 1. Overweight or obese as defined by a BMI>=23 2. Diagnosed to have polycystic ovarian syndrome according to the Rotterdam criteria by presence of any two out of the following: oligo/anovulation, clinical and/or biochemical evidence of hyperandrogenism, polycystic ovaries by ultrasound. 3. Giving informed consent

Exclusion criteria

Exclusion criteria: 1. Causes of secondary PCOS including hyperprolactinemia, hypothyroidism, Cushingâ??s syndrome, adrenal and ovarian androgen secreting tumors, patients on medications thought to cause PCOS like valproate. 2. Liver disease or renal impairment 3. Diabetes mellitus 4. Intake of any drugs for PCOS treatment in past 3months 5. Ovarian drilling or any ovarian surgical procedures in the past 6 months 6. Not consenting to the study

Design outcomes

Primary

Measure	Time frame
Changes in serum anti-Mullerian hormone (AMH)Timepoint: Baseline (at the time of recruitment) and after completing 3 months of treatment	—

Secondary

Measure	Time frame
â?¢Changes in serum testosterone, free androgen index (FAI), LH:FSH ratio â?¢Changes in HOMA IR, HbA1C, fasting lipid profile â?¢Changes in body weight, BMI, waist circumference, modified Ferriman-Gallwey score, Global acne score â?¢Changes in ovarian volume and morphology on pelvic ultrasound Timepoint: Baseline (at the time of recruitment) and after completing 3 months of treatment	—

Countries

India

Contacts

Public ContactRoshan Nazirudeen

Madurai Medical College

drsridharjipmer@gmail.com06384100266

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026