Actively Recruiting
Impact of Adding Quercetin or Alpha Lipoic Acid on Clinical and Biochemical Outcomes in Iraqi Women with Polycystic Ovary Syndrome
Led by Al-Mustansiriyah University · Updated on 2025-09-19
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding Quercetin or Alpha-Lipoic Acid (ALA) to standard metformin therapy can improve hormone levels, metabolic health, symptoms, and quality of life in women with polycystic ovary syndrome (PCOS). The study focuses on differences in hormonal balance, blood sugar control, cholesterol, antioxidant markers, medication adherence, and patient-reported well-being. This Phase 2 trial is sponsored by Al-Mustansiriyah University and targets women newly diagnosed with PCOS who meet specific clinical criteria. Participants will be randomly assigned to one of three groups for a 3-month treatment period: metformin 500 mg daily alone, metformin 500 mg plus Quercetin 500 mg daily, or metformin 500 mg plus ALA 600 mg sustained release daily. All treatments are taken orally once daily after a meal. Researchers will monitor the effects of these regimens on hormonal and metabolic markers, along with quality of life and medication adherence. During the study, participants will provide fasting blood samples at the start and after 3 months to measure hormones, glucose, insulin, lipids, and oxidative stress biomarkers. They will complete questionnaires assessing quality of life and medication adherence, undergo physical measurements including weight, BMI, waist/hip circumference, and blood pressure, and report any side effects. Safety and overall benefits will be evaluated throughout the study.
CONDITIONS
Brief Title
Effects of Adding Quercetin or Alpha Lipoic Acid to Usual Care on Symptoms and Blood Markers in Iraqi Women With Polycystic Ovary Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 40 years
- Newly diagnosed with polycystic ovary syndrome
- Presence of micro polycystic ovaries confirmed by ultrasound
- Irregular menstrual cycles with intervals longer than 35 days
- Clinical or biochemical signs of increased male hormones such as acne or hirsutism
- Normal prolactin levels
You will not qualify if you...
- Presence of enzymatic adrenal deficiency or other endocrine diseases, including diabetes
- Other comorbid conditions such as hypertension, cardiovascular disease, or hormonal dysfunction
- Use of oral contraceptives, hormonal therapy, or anti-lipidemic drugs
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants take their assigned oral treatments once daily after a meal for 3 months and provide fasting blood samples and complete questionnaires at baseline and month 3. Physical measurements and side effect reports are also collected.
2 visits (baseline and month 3)
Trial Site Locations
Total: 1 location
1
Mustansiriyah University/ College of Pharmacy
Baghdad, Karkh, Iraq, 00964
Actively Recruiting
Research Team
M
Mohammed Mahmood Mohammed, professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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