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

Not Applicable

Recruiting

• Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
• Interventions: Drug: Quercetin; Drug: Alpha Lipoic Acid 600 MG Oral Tablet; Drug: MetFORMIN 500 Mg Oral Tablet

• Registration Number: NCT07182526
• Lead Sponsor: Al-Mustansiriyah University

Brief 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.

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 Timeline

• Study First Submitted: 2025-05-29
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-18
• Last Update Submitted: 2025-09-18
• Study First Posted: 2025-09-19
• Last Update Posted: 2025-09-19
• Study Start: 2025-09-20
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quercetin group	Quercetin	patients assigned to be treated with metformin 500 mg plus a daily dose of Quercetin 500 mg capsule after meal for three months period.
Quercetin group	MetFORMIN 500 Mg Oral Tablet	patients assigned to be treated with metformin 500 mg plus a daily dose of Quercetin 500 mg capsule after meal for three months period.
Alpha lipoic acid group	Alpha Lipoic Acid 600 MG Oral Tablet	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.
Alpha lipoic acid group	MetFORMIN 500 Mg Oral Tablet	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.
Control group	MetFORMIN 500 Mg Oral Tablet	patients assigned to be treated with metformin 500 mg daily

Primary Outcome Measures

Name	Time	Method
Change in Hormonal Profile (LH, FSH, Testosterone) from Baseline	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.
Change in Glycemic Control Markers (Fasting Glucose, Insulin, HOMA-IR) from Baseline	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 Outcome Measures

Name	Time	Method
Change in Lipid Profile (Total Cholesterol, LDL-C, HDL-C, Triglycerides) from Baseline	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.
Change in Oxidative Stress and Related Biomarkers (Fibulin-1, Kisspeptin, SOD1, GPx) from Baseline	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.
Change in Quality of Life (PCOSQ Total Score) from Baseline	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.
Change in Medication Adherence (4-Item Morisky Scale Score) from Baseline	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.

Trial Locations

Locations (1)

Mustansiriyah University/ College of Pharmacy; 🇮🇶 Baghdad, Karkh, Iraq