PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Conditions
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
Interventions
DRUGQuercetin
Quercetin 500 mg capsule daily after meal for three months
Alpha lipoic acid 600mg SR capsule daily after meal for three months period.
metformin 500 mg daily for three months
Sponsors
Al-Mustansiriyah University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Iraq
Contacts
Primary ContactMohammed Mahmood Mohammed, professor
Outcome results
None listed