PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesPhase 2NCT07182526
Effects of Adding Quercetin or Alpha Lipoic Acid to Usual Care on Symptoms and Blood Markers in Iraqi Women With Polycystic Ovary Syndrome
A Phase 2 study testing Quercetin, Alpha Lipoic Acid 600 MG Oral Tablet and MetFORMIN 500 Mg Oral Tablet in people with PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, run by Al-Mustansiriyah University at 1 site in Iraq.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
- What is being tested?
- Quercetin, Alpha Lipoic Acid 600 MG Oral Tablet and MetFORMIN 500 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIraq
- Study dates
- 20 Sep 2025to 1 May 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohammed Mahmood Mohammed, professor contact
Iraq1 site, 1 recruiting
- Recruiting
Mustansiriyah University/ College of Pharmacy
Baghdad, Karkh, 00964
Inaam Arif, PhD, 7902260203 ext. +964, pharm.dr.isamalhaj@uomuatansiriyah.edu.iq
About this study
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
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.
Read the 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
- Being tested
- Quercetin, Alpha Lipoic Acid 600 MG Oral Tablet, MetFORMIN 500 Mg Oral Tablet
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuercetinDrug
Also called Quercetin 500 mg capsule, NOW pharmacetics
Quercetin 500 mg capsule daily after meal for three months
Alpha Lipoic Acid 600 MG Oral TabletDrug
Also called Alpha lipoic acid 600 mg oral Tablet, Nutricost pharmacetics
Alpha lipoic acid 600mg SR capsule daily after meal for three months period.
MetFORMIN 500 Mg Oral TabletDrug
Also called Glucophage 500 Mg Oral Tablet, Merck pharmacetics
metformin 500 mg daily for three months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Drug: MetFORMIN 500 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 3 months after starting assigned treatment
Secondary outcomes (4)
Change in Lipid Profile (Total Cholesterol, LDL-C, HDL-C, Triglycerides) from Baseline
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.
Measured: Baseline and 3 months after starting assigned treatment
Change in Oxidative Stress and Related Biomarkers (Fibulin-1, Kisspeptin, SOD1, GPx) from Baseline
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.
Measured: Baseline and 3 months after starting assigned treatment
Change in Quality of Life (PCOSQ Total Score) from Baseline
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.
Measured: Baseline and 3 months after starting assigned treatment
Change in Medication Adherence (4-Item Morisky Scale Score) from Baseline
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.
Measured: Baseline and 3 months after starting assigned treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start20 Sep 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Mahmood Mohammed, Al-Mustansiriyah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182526
- Sponsor's protocol ID
- Mustansiriyah University/ 85
- Status last verified
- Sep 2025
- First submitted
- 29 May 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07182526
- Acronym / sponsor ID
- Mustansiriyah University/ 85
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Quercetin group | Experimental | Drug: Quercetin, Drug: MetFORMIN 500 Mg Oral Tabletpatients assigned to be treated with metformin 500 mg plus a daily dose of Quercetin 500 mg capsule after meal for three months period. |
| Alpha lipoic acid group | Experimental | Drug: Alpha Lipoic Acid 600 MG Oral Tablet, Drug: MetFORMIN 500 Mg Oral Tabletpatients 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. |
| Control group | Active comparator | Drug: MetFORMIN 500 Mg Oral Tabletpatients assigned to be treated with metformin 500 mg daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Newly diagnosed patients should be at reproductive aged from 18-40 years.
Key exclusion criteria (4 listed)
- • Presence of enzymatic adrenal deficiency and/or other endocrine disease, including diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuercetinAlso: Quercetin 500 mg capsule, NOW pharmaceticsQuercetin 500 mg capsule daily after meal for three months | Drug | Quercetin group |
| Alpha Lipoic Acid 600 MG Oral TabletAlso: Alpha lipoic acid 600 mg oral Tablet, Nutricost pharmaceticsAlpha lipoic acid 600mg SR capsule daily after meal for three months period. | Drug | Alpha lipoic acid group |
| MetFORMIN 500 Mg Oral TabletAlso: Glucophage 500 Mg Oral Tablet, Merck pharmaceticsmetformin 500 mg daily for three months | Drug | Alpha lipoic acid group, Control group, Quercetin group |
Primary outcome
Change in Hormonal Profile (LH, FSH, Testosterone) from Baseline
Time frame: 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
Time frame: 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.
4 secondary outcomes
Change in Lipid Profile (Total Cholesterol, LDL-C, HDL-C, Triglycerides) from Baseline
Time frame: Baseline and 3 months after starting assigned treatment
Change in Oxidative Stress and Related Biomarkers (Fibulin-1, Kisspeptin, SOD1, GPx) from Baseline
Time frame: Baseline and 3 months after starting assigned treatment
Change in Quality of Life (PCOSQ Total Score) from Baseline
Time frame: Baseline and 3 months after starting assigned treatment
Change in Medication Adherence (4-Item Morisky Scale Score) from Baseline
Time frame: Baseline and 3 months after starting assigned treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
RecruitingPhase 3
Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Obese
Active, not recruiting
Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Dysglycemia
Not yet recruitingObservational study
Evaluation of Fibromyalgia Frequency and Pain Parameters in Women With Polycystic Ovary Syndrome
Fibromyalgia, PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Recruiting
Best Treatment for Women With Both (Polycystic Ovary Syndrome) PCOS and Subclinical Hypothyroidism
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Subclinical Hypothyroidism
Not yet recruitingObservational study
Laboratory and Ultrasound Findings and Response to Letrozole in PCOS Patients
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammed Mahmood Mohammed, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Quercetin, Alpha Lipoic Acid 600 MG Oral Tablet and MetFORMIN 500 Mg Oral Tablet in people with PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, run by Al-Mustansiriyah University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Mahmood Mohammed, professor (7816871131 ext. +964, pharm.drmhdclinical@uomustansiriyah.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hormonal Profile (LH, FSH, Testosterone) from Baseline (time frame: Baseline and 3 months after starting assigned treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.