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NCT Number: NCT07182526

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

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.

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Key information

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mustansiriyah University/ College of Pharmacy

Baghdad, Karkh, 00964, Iraq

Location status: Recruiting

Location contact

Inaam Arif, PhD

CONTACT

[email protected]

7902260203 ext. +964

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 criteria

  • • Presence of enzymatic adrenal deficiency and/or other endocrine disease, including diabetes.
  • Other comorbidities (such as hypertension, cardiovascular disease, or hormonal dysfunction).
  • Women who used oral contraceptives, hormonal therapy, or anti-lipidemic drugs.
  • Pregnant women.

Treatment and study plan

Quercetin

Drug

Quercetin 500 mg capsule daily after meal for three months

Other names: Quercetin 500 mg capsule, NOW pharmacetics

Alpha Lipoic Acid 600 MG Oral Tablet

Drug

Alpha lipoic acid 600mg SR capsule daily after meal for three months period.

Other names: Alpha lipoic acid 600 mg oral Tablet, Nutricost pharmacetics

MetFORMIN 500 Mg Oral Tablet

Drug

metformin 500 mg daily for three months

Other names: Glucophage 500 Mg Oral Tablet, Merck pharmacetics

Primary outcomes

  1. Change in Hormonal Profile (LH, FSH, Testosterone) from Baseline

    Time frame: Baseline and 3 months after starting assigned treatment

    Serum luteinizing hormone (LH), follicle-stimulating hormone (FSH), and total testosterone levels will be measured in fasting blood samples. Changes from baseline to 3 months will be compared between groups to assess improvement in hormonal balance in women with PCOS.

  2. Change in Glycemic Control Markers (Fasting Glucose, Insulin, HOMA-IR) from Baseline

    Time frame: Baseline and 3 months after starting assigned treatment

    Fasting plasma glucose and insulin will be measured, and the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated. Changes from baseline to 3 months will be compared between groups to evaluate improvements in glycemic control.

Secondary outcomes

  1. Change in Lipid Profile (Total Cholesterol, LDL-C, HDL-C, Triglycerides) from Baseline

    Time frame: Baseline and 3 months after starting assigned treatment

    Fasting lipid panel will be assessed, including total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides. Changes from baseline to 3 months will be compared between groups.

  2. Change in Oxidative Stress and Related Biomarkers (Fibulin-1, Kisspeptin, SOD1, GPx) from Baseline

    Time frame: Baseline and 3 months after starting assigned treatment

    Serum levels of fibulin-1, kisspeptin, superoxide dismutase 1 (SOD1), and glutathione peroxidase (GPx) will be measured in fasting blood samples. Changes from baseline to 3 months will be compared between groups to assess antioxidant and oxidative stress status.

  3. Change in Quality of Life (PCOSQ Total Score) from Baseline

    Time frame: Baseline and 3 months after starting assigned treatment

    The Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ) will be administered. Changes in total score from baseline to 3 months will be compared between groups to evaluate patient-reported well-being.

  4. Change in Medication Adherence (4-Item Morisky Scale Score) from Baseline

    Time frame: Baseline and 3 months after starting assigned treatment

    The 4-item Morisky Medication Adherence Scale will be used to assess adherence to assigned treatment. Changes in score from baseline to 3 months will be compared between groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed Mahmood Mohammed, professor

CONTACT

[email protected]

7816871131 ext. +964

Sponsors and collaborators

Lead sponsor

Al-Mustansiriyah University

Other

Registry information

Official study title

Impact of Adding Quercetin or Alpha Lipoic Acid as an Adjuvant Therapy on Clinical and Biochemical Outcomes in a Sample of Iraqi PCOS Patients

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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