Effects of Adding Quercetin or Alpha Lipoic Acid to Usual Care on Symptoms and Blood Markers in Iraqi Women With Polycystic Ovary Syndrome

Last updated: September 18, 2025
Sponsor: Al-Mustansiriyah University
Overall Status: Active - Recruiting

Phase

2

Condition

Polycystic Ovarian Syndrome

Reproductive Health

Treatment

MetFORMIN 500 Mg Oral Tablet

Quercetin

Alpha Lipoic Acid 600 MG Oral Tablet

Clinical Study ID

NCT07182526
Mustansiriyah University/ 85
  • Ages > 18
  • All Genders

Study Summary

This study will investigate whether the addition of Quercetin or Alpha-Lipoic Acid (ALA) to standard metformin therapy can improve symptoms, hormone levels, metabolic health, and quality of life in women with polycystic ovary syndrome (PCOS). Over 3 months, participants will be randomly assigned to one of three groups: metformin alone, metformin plus Quercetin, or metformin plus ALA. Researchers will measure changes in hormones, blood sugar, cholesterol, and antioxidant markers, as well as quality of life and medication adherence. Physical measurements and side effects will also be recorded to assess safety and overall benefit.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • • Newly diagnosed patients should be at reproductive aged from 18-40 years.

  • Patients diagnosed with presence of micro polycystic ovaries at ultrasound.

  • Oligomenorrhea with inter-menstrual intervals longer than 35 days.

  • Clinical or biochemical signs of hyperandrogenism (acne, hirsutism).

  • Normal PRL levels.

Exclusion

Exclusion Criteria:

  • • Presence of enzymatic adrenal deficiency and/or other endocrine disease, includingdiabetes.

  • Other comorbidities (such as hypertension, cardiovascular disease, or hormonaldysfunction).

  • Women who used oral contraceptives, hormonal therapy, or anti-lipidemic drugs.

  • Pregnant women.

Study Design

Total Participants: 150
Treatment Group(s): 3
Primary Treatment: MetFORMIN 500 Mg Oral Tablet
Phase: 2
Study Start date:
September 20, 2025
Estimated Completion Date:
May 01, 2026

Study Description

The goal of this clinical trial is to learn if adding Quercetin or Alpha-Lipoic Acid (ALA) to metformin can better treat PCOS symptoms and improve safety, metabolic health, and quality of life in women.

The main questions it aims to answer are:

  • Does metformin + Quercetin or metformin + ALA improve hormonal balance (e.g., LH, FSH, testosterone) more than metformin alone?

  • Do these combinations enhance glycemic control (fasting glucose, insulin, HOMA-IR), lipid profiles, and oxidative-stress markers (fibulin-1, kisspeptin, SOD1, GPx)?

  • How do these regimens affect patient-reported outcomes like quality of life (PCOSQ) and medication adherence?

Researchers will compare three groups to see which regimen yields the greatest improvements:

  • Metformin 500 mg daily alone

  • Metformin 500 mg + Quercetin 500 mg daily

  • Metformin 500 mg + ALA 600 mg SR daily

Participants will:

  • Take their assigned oral treatments once daily after a meal for 3 months

  • Provide fasting blood samples at baseline and month 3 for hormone, glucose/insulin, lipid, and antioxidant assays

  • Complete the PCOSQ quality-of-life questionnaire and the 4-item Morisky adherence scale at both visits

  • Undergo physical measurements (weight, BMI, waist/hip circumference, blood pressure) and report any side effects

Connect with a study center

  • Mustansiriyah University/ College of Pharmacy

    Baghdad 98182, Karkh 00964
    Iraq

    Active - Recruiting

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