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

September 18, 2025 updated by: Mohammed Mahmood Mohammed, Al-Mustansiriyah University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Quercetin group
patients assigned to be treated with metformin 500 mg plus a daily dose of Quercetin 500 mg capsule after meal for three months period.
Drug: Quercetin
Quercetin 500 mg capsule daily after meal for three months
Other Names:
  • Quercetin 500 mg capsule, NOW pharmacetics
Drug: MetFORMIN 500 Mg Oral Tablet
metformin 500 mg daily for three months
Other Names:
  • Glucophage 500 Mg Oral Tablet, Merck pharmacetics
Experimental: Alpha lipoic acid group
patients assigned to be treated with metformin 500 mg plus a daily dose of Alpha lipoic acid 600mg SR capsule after meal for three months period.
Drug: MetFORMIN 500 Mg Oral Tablet
metformin 500 mg daily for three months
Other Names:
  • Glucophage 500 Mg Oral Tablet, Merck pharmacetics
Drug: Alpha Lipoic Acid 600 MG Oral Tablet
Alpha lipoic acid 600mg SR capsule daily after meal for three months period.
Other Names:
  • Alpha lipoic acid 600 mg oral Tablet, Nutricost pharmacetics
Active Comparator: Control group
patients assigned to be treated with metformin 500 mg daily
Drug: MetFORMIN 500 Mg Oral Tablet
metformin 500 mg daily for three months
Other Names:
  • Glucophage 500 Mg Oral Tablet, Merck pharmacetics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 3 months after starting assigned treatment
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.
Baseline and 3 months after starting assigned treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 3 months after starting assigned treatment
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.
Baseline and 3 months after starting assigned treatment
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.
Baseline and 3 months after starting assigned treatment
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.
Baseline and 3 months after starting assigned treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Mustansiriyah University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 20, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

May 29, 2025

First Submitted That Met QC Criteria

September 18, 2025

First Posted (Estimated)

September 19, 2025

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 18, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mustansiriyah University/ 85

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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