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

Phase 2RecruitingNCT07182526

Al-Mustansiriyah University150 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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.