Adding quercetin or alpha-lipoic acid to metformin for women with PCOS
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 trial will see if adding quercetin or alpha-lipoic acid to metformin improves hormones, blood sugar, cholesterol, and quality of life in women aged 18–40 with PCOS.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Al-Mustansiriyah University Academic / other |
| Locations | 1 site (Baghdad, Karkh) |
| Trial ID | NCT07182526 on ClinicalTrials.gov |
What this trial studies
Women aged 18–40 with newly diagnosed PCOS will be randomly assigned for three months to one of three once-daily regimens: metformin alone, metformin plus quercetin (500 mg), or metformin plus sustained-release alpha-lipoic acid (600 mg). Fasting blood samples at baseline and month 3 will measure hormones, glucose/insulin, lipids, and oxidative-stress markers, while weight, blood pressure, and side effects will be recorded. Participants will complete the PCOSQ quality-of-life questionnaire and a 4-item medication adherence scale at both visits. The randomized, parallel-group design compares metabolic, hormonal, antioxidant, and patient-reported outcomes between regimens to judge safety and benefit.
Who should consider this trial
Good fit: Ideal candidates are women 18–40 with newly diagnosed PCOS defined by polycystic ovaries on ultrasound, oligomenorrhea, clinical or biochemical hyperandrogenism, normal prolactin, and no diabetes or other major endocrine or cardiovascular conditions.
Not a fit: Patients who are pregnant, have diabetes or other excluded comorbid endocrine or cardiovascular diseases, are already taking hormonal or lipid-lowering therapies, or cannot attend the Baghdad study site are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding quercetin or ALA could offer a low-cost way to improve hormonal balance, metabolic health, and quality of life for women with PCOS.
How similar studies have performed: Small clinical and preclinical studies suggest quercetin and ALA can improve insulin resistance, lipid profiles, and oxidative-stress markers, but large randomized trials in PCOS are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Baghdad, Karkh
- Mustansiriyah University/ College of Pharmacy — Baghdad, Karkh, Iraq (Recruiting)
Study contacts
- Study coordinator: Mohammed Mahmood Mohammed, professor
- Email: pharm.drmhdclinical@uomustansiriyah.edu.iq
- Phone: 7816871131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.