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Myo-Inositol and D-Chiro-Inositol for Menstrual Irregularities and Hormone Changes in Women With Polycystic Ovarian Syndrome
Sponsor: Nishtar Medical University
Summary
The goal of this clinical trial is to determine whether a combination of myo-inositol (MI) and D-chiro-inositol (DCI) with folic acid is more effective than placebo (Folic acid alone) in improving menstrual irregularities and hormone levels in women with polycystic ovarian syndrome (PCOS). The main questions this study aims to answer are: 1. Does treatment with myo-inositol and D-chiro-inositol improve menstrual regularity in women with PCOS compared with placebo? 2. Does the treatment improve biochemical characteristics, including luteinizing hormone (LH), follicle-stimulating hormone (FSH), and testosterone levels, compared with placebo? Researchers will compare a combination of myo-inositol and D-chiro-inositol with a placebo (folic acid alone) to determine whether the combination therapy is more effective in treating PCOS-related menstrual and hormonal abnormalities. Participants will: * Be randomly assigned to receive either a myo-inositol and D-chiro-inositol combination tablet (40:1 ratio) or placebo twice daily for 3 months. * Have blood samples collected before starting treatment and after 3 months to measure LH, FSH, and testosterone levels. * Attend monthly follow-up visits during the 3-month treatment period to assess changes in menstrual regularity and monitor their progress. The study will enroll 60 women aged 18-45 years with PCOS at the Department of Obstetrics and Gynecology, Nishtar Hospital Multan. The results may help determine whether myo-inositol and D-chiro-inositol combination therapy is an effective treatment for improving menstrual function and hormonal abnormalities in women with PCOS.
Official title: Effect of Myo-Inositol and D-Chiro-Inositol Combination Therapy on Improvement in Menstrual Irregularities and Biochemical Characteristics in Patients With Polycystic Ovarian Syndrome
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-06-01
Completion Date
2025-11-30
Last Updated
2026-07-14
Healthy Volunteers
No
Interventions
Myo-Inositol and D-Chiro-Inositol Combination Therapy
Participants will receive an oral combination tablet containing myo-inositol (550 mg), D-chiro-inositol (13.8 mg) in a 40:1 ratio, and folic acid (200 µg), taken twice daily for 3 months.
placebo (folic acid)
Participants will receive oral folic acid (200 µg) tablets twice daily for 3 months.
Locations (1)
Nishtar Medical University and Hospital Multan
Multan, Punjab Province, Pakistan