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

NCT07182526 · Al-Mustansiriyah University
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Official title
Impact of Adding Quercetin or Alpha Lipoic Acid as an Adjuvant Therapy on Clinical and Biochemical Outcomes in a Sample of Iraqi PCOS Patients
About this study
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
Eligibility criteria
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
Enrollment target: 150 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-09-20
Estimated completion: 2026-05-01
Last updated: 2025-09-19
Interventions
Drug: QuercetinDrug: Alpha Lipoic Acid 600 MG Oral TabletDrug: MetFORMIN 500 Mg Oral Tablet
Primary outcomes
  • Change in Hormonal Profile (LH, FSH, Testosterone) from Baseline (Baseline and 3 months after starting assigned treatment)
  • Change in Glycemic Control Markers (Fasting Glucose, Insulin, HOMA-IR) from Baseline (Baseline and 3 months after starting assigned treatment)
Sponsor
Al-Mustansiriyah University · other
Contacts & investigators
ContactMohammed Mahmood Mohammed, professor · contact · pharm.drmhdclinical@uomustansiriyah.edu.iq · 7816871131
All locations (1)
Mustansiriyah University/ College of PharmacyRecruiting
Baghdad, Karkh, Iraq
Effects of Adding Quercetin or Alpha Lipoic Acid to Usual Care on Symptoms and Blood Markers in Iraqi Women With Polycystic Ovary Syndrome · TrialPath