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
Phase 4
- Conditions
- Health Condition 1: E282- Polycystic ovarian syndrome
- Registration Number
- CTRI/2022/10/046460
- Lead Sponsor
- AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Insulin resistance (HOMA-IR) <br/ ><br>Polycystic ovarian morphology <br/ ><br>Hyperlipidemia <br/ ><br>Hyperandrogenism <br/ ><br>Timepoint: 12 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method •To study the side effects of myo-inositol plus folic acid, metformin plus folic acid and metformin. <br/ ><br>•To compare the side effects of the medication used in all the three groups. <br/ ><br>•To compare rate of conception in infertile women with PCOS in all three groups. <br/ ><br>•To compare cost effectiveness of the treatment options all three groups. <br/ ><br> <br/ ><br>Timepoint: in 12 weeks comparison