NCT07182526

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Al-Mustansiriyah University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Interventions

Type	Name	Description
DRUG	Quercetin	Quercetin 500 mg capsule daily after meal for three months
DRUG	Alpha Lipoic Acid 600 MG Oral Tablet	Alpha lipoic acid 600mg SR capsule daily after meal for three months period.
DRUG	MetFORMIN 500 Mg Oral Tablet	metformin 500 mg daily for three months

Timeline

• Start date: 2025-09-20
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-09-19
• Last updated: 2025-09-19

Locations

1 site across 1 country: Iraq