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

Al-Mustansiriyah University

Status and phase: Enrolling; Phase 2

Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Treatments: Drug: MetFORMIN 500 Mg Oral Tablet; Drug: Quercetin; Drug: Alpha Lipoic Acid 600 MG Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT07182526

Mustansiriyah University/ 85

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Quercetin group

Experimental group

Description:

patients assigned to be treated with metformin 500 mg plus a daily dose of Quercetin 500 mg capsule after meal for three months period.

Treatment:

Drug: Quercetin

Drug: MetFORMIN 500 Mg Oral Tablet

Alpha lipoic acid group

Experimental group

Description:

patients assigned to be treated with metformin 500 mg plus a daily dose of Alpha lipoic acid 600mg SR capsule after meal for three months period.

Treatment:

Drug: Alpha Lipoic Acid 600 MG Oral Tablet

Drug: MetFORMIN 500 Mg Oral Tablet

Control group

Active Comparator group

Description:

patients assigned to be treated with metformin 500 mg daily

Treatment:

Drug: MetFORMIN 500 Mg Oral Tablet