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

NCT ID: NCT07182526

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-20
• Study Completion Date: 2026-05-01

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

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Quercetin group

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

Group Type: EXPERIMENTAL

Quercetin

Intervention Type: DRUG

Quercetin 500 mg capsule daily after meal for three months

MetFORMIN 500 Mg Oral Tablet

Intervention Type: DRUG

metformin 500 mg daily for three months

Alpha lipoic acid group

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.

Group Type: EXPERIMENTAL

Alpha Lipoic Acid 600 MG Oral Tablet

Intervention Type: DRUG

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

MetFORMIN 500 Mg Oral Tablet

Intervention Type: DRUG

metformin 500 mg daily for three months

Control group

patients assigned to be treated with metformin 500 mg daily

Group Type: ACTIVE_COMPARATOR

MetFORMIN 500 Mg Oral Tablet

Intervention Type: DRUG

metformin 500 mg daily for three months

Interventions

Quercetin

Quercetin 500 mg capsule daily after meal for three months

Intervention Type: DRUG

Alpha Lipoic Acid 600 MG Oral Tablet

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

Intervention Type: DRUG

MetFORMIN 500 Mg Oral Tablet

metformin 500 mg daily for three months

Intervention Type: DRUG

Other Intervention Names

Quercetin 500 mg capsule, NOW pharmacetics; Alpha lipoic acid 600 mg oral Tablet, Nutricost pharmacetics; Glucophage 500 Mg Oral Tablet, Merck pharmacetics

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Mustansiriyah University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Mahmood Mohammed

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mustansiriyah University/ College of Pharmacy

Baghdad, Karkh, Iraq

Site Status: RECRUITING

Countries

Iraq

Central Contacts

Mohammed Mahmood Mohammed, professor

Role: CONTACT

pharm.drmhdclinical@uomustansiriyah.edu.iq

7816871131 ext. +964

Facility Contacts

Inaam Arif, PhD

Role: primary

pharm.dr.isamalhaj@uomuatansiriyah.edu.iq

7902260203 ext. +964

Other Identifiers

Mustansiriyah University/ 85

Identifier Type: -

Identifier Source: org_study_id