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The effect of myo-inositol with folic acid and metformin with folic acid v/s metformin alone in management of PCOS: A three arm Randomized Trial

The effect of myo-inositol with folic acid and metformin with folic acid v/s metformin alone in management of PCOS: A three arm Randomized Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046460
Enrollment
105
Registered
2022-10-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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: Myoinositol 2000 mg + folic acid 200µg once daily for 12 weeks Intervention2: metformin plus folic acid: metformin 500 mg three times daily plus folic acid 500 mcg once da

Sponsors

AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women in age group of 18 to 35 years with PCOS as per Rotterdam’s criteria patients of naïve PCOS with or without infertility.

Exclusion criteria

Exclusion criteria: Known case of PCOS who is already on any treatment for PCOS/infertility for past 3 months. Patient with galactorrhea and clinically diagnosed and known case of Cushing syndrome. Patients detected with presence of abnormal ovarian cyst. History of hormonal pills intake for the duration of past 3 months. Pregnancy Patients with type 2 DM

Design outcomes

Primary

MeasureTime frame
Insulin resistance (HOMA-IR) Polycystic ovarian morphology Hyperlipidemia Hyperandrogenism Timepoint: 12 weeks

Secondary

MeasureTime frame
• To study the side effects of myo-inositol plus folic acid, metformin plus folic acid and metformin. • To compare the side effects of the medication used in all the three groups. • To compare rate of conception in infertile women with PCOS in all three groups. • To compare cost effectiveness of the treatment options all three groups. Timepoint: in 12 weeks comparison

Countries

India

Contacts

Public ContactDR PUSHPA KOTUR

AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL

pushpavishvanath.kotur@avmc.edu.in9449287811

Outcome results

None listed

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