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

NCT07182526 | Recruiting Phase 2 DMC

• 1 other identifier: Mustansiriyah University/ 85
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and 3 months after starting assigned treatment

• 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.

  Baseline and 3 months after starting assigned treatment

Secondary Outcomes (4)

• Change in Lipid Profile (Total Cholesterol, LDL-C, HDL-C, Triglycerides) from Baseline

  Baseline and 3 months after starting assigned treatment

• Change in Oxidative Stress and Related Biomarkers (Fibulin-1, Kisspeptin, SOD1, GPx) from Baseline

  Baseline and 3 months after starting assigned treatment

• Change in Quality of Life (PCOSQ Total Score) from Baseline

  Baseline and 3 months after starting assigned treatment

• Change in Medication Adherence (4-Item Morisky Scale Score) from Baseline

  Baseline and 3 months after starting assigned treatment

Study Arms (3)

Quercetin group

EXPERIMENTAL

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

Drug: Quercetin; Drug: MetFORMIN 500 Mg Oral Tablet

Alpha lipoic acid group

EXPERIMENTAL

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.

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

Control group

ACTIVE COMPARATOR

patients assigned to be treated with metformin 500 mg daily

Drug: MetFORMIN 500 Mg Oral Tablet

Interventions

Quercetin DRUG

Quercetin 500 mg capsule daily after meal for three months

Also known as: Quercetin 500 mg capsule, NOW pharmacetics

Quercetin group

Alpha Lipoic Acid 600 MG Oral Tablet DRUG

Alpha lipoic acid 600mg SR capsule daily after meal for three months period.

Also known as: Alpha lipoic acid 600 mg oral Tablet, Nutricost pharmacetics

Alpha lipoic acid group

MetFORMIN 500 Mg Oral Tablet DRUG

metformin 500 mg daily for three months

Also known as: Glucophage 500 Mg Oral Tablet, Merck pharmacetics

Alpha lipoic acid group; Control group; Quercetin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Mustansiriyah University: lead

Study Sites (1)

Mustansiriyah University/ College of Pharmacy

Baghdad, Karkh, 00964, Iraq

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Quercetin; Capsules; Thioctic Acid; Tablets; Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dosage Forms; Pharmaceutical Preparations; Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Biguanides; Guanidines; Amidines

Central Study Contacts

Mohammed Mahmood Mohammed, professor

CONTACT

7816871131; pharm.drmhdclinical@uomustansiriyah.edu.iq

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: September 19, 2025
• Study Start: September 20, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

IR (1)