A Phase 4 interventional study of Myo-Inositol and D-Chiro-Inositol Combination Therapy and placebo (folic acid) in Polycystic Ovary Syndrome (PCOS), Myo-inositol and D-chiro-inositol, sponsored by Nishtar Medical University. Completed at 1 site in Pakistan. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Nishtar Medical University · Phase 4, Interventional, and Treatment
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:
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:
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.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's enrollment of 60 is below the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Nishtar Medical University is the lead sponsor of 29 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Participants will receive a combination tablet containing myo-inositol, D-chiro-inositol, and folic acid
Drug: Myo-Inositol and D-Chiro-Inositol Combination Therapy
Participants will receive folic acid tablets orally
Drug: placebo (folic acid)
Drug pages: Inositol · Chiro-inositol, (+)-
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.
Improvement in Menstrual Irregularity
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.
Time frame: From enrollment to the end of treatment at 3 months
Serum LH, FSH, and Testosterone levels
Serum FSH, LH, and testosterone concentration measured using venous blood samples collected before treatment and after 3 months of therapy.
Time frame: At baseline at enrollment to the end of treatment at 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Inositol · Chiro-inositol, (+)-
Nishtar Medical University