D-chiro-inositol, Myo-inositol, Polycystic Ovary Syndrome (PCOS)
Conditions
Keywords
Menstrual Irregularities, Oligomenorrhea, Amenorrhea, Menorrhagia, Hyperandrogenism, Testosterone, Luteinizing Hormone, Follicle-Stimulating Hormone, PCOS
Brief 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.
Interventions
DRUGMyo-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.
Participants will receive oral folic acid (200 µg) tablets twice daily for 3 months.
Sponsors
Nishtar Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* diagnosed case of PCOS, ≥ 6-months
Exclusion criteria
* Hyperprolactinemia, hypothyroidism, adrenal hyperplasia or Cushing's syndrome (on history \& medical record review)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Menstrual Irregularity | From enrollment to the end of treatment at 3 months | The proportion of participants achieving improvement in menstrual irregularity after treatment. Improvement is defined as restoration of a regular menstrual cycle with an average cycle length of 24-32 days and menstrual blood loss of 21-50 mL per cycle. Menstrual irregularity includes amenorrhea, oligomenorrhea, or menorrhagia assessed through participant menstrual history. |
Countries
Pakistan
Contacts
STUDY_CHAIRMehnaz K Professor, FCPS
Nishtar Medical University and Hospital Multan
Outcome results
None listed