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.
• 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).
• 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.
Parallel
Quercetin
DrugQuercetin 500 mg capsule daily after meal for three months
Alpha Lipoic Acid 600 MG Oral Tablet
DrugAlpha lipoic acid 600mg SR capsule daily after meal for three months period.
MetFORMIN 500 Mg Oral Tablet
Drugmetformin 500 mg daily for three months
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.
Change in Glycemic Control Markers (Fasting Glucose, Insulin, HOMA-IR) from Baseline
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.
Change in Lipid Profile (Total Cholesterol, LDL-C, HDL-C, Triglycerides) from Baseline
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
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
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
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.
Click on the lead sponsor to view all of their trials.
