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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.
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:
Researchers will compare three groups to see which regimen yields the greatest improvements:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Control group | Active Comparator | patients assigned to be treated with metformin 500 mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quercetin | Drug | Quercetin 500 mg capsule daily after meal for three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 3 months after starting assigned treatment |
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Inclusion Criteria:
• Newly diagnosed patients should be at reproductive aged from 18-40 years.
Exclusion Criteria:
• Presence of enzymatic adrenal deficiency and/or other endocrine disease, including diabetes.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammed Mahmood Mohammed, professor | Contact | 7816871131 | +964 | pharm.drmhdclinical@uomustansiriyah.edu.iq |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mustansiriyah University/ College of Pharmacy | Recruiting | Baghdad | Karkh | 00964 | Iraq |
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| Alpha Lipoic Acid 600 MG Oral Tablet | Drug | Alpha lipoic acid 600mg SR capsule daily after meal for three months period. |
|
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| MetFORMIN 500 Mg Oral Tablet | Drug | metformin 500 mg daily for three months |
|
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| 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. | 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. | 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. | Baseline and 3 months after starting assigned treatment |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D011794 | Quercetin |
| D002214 | Capsules |
| D008063 | Thioctic Acid |
| D013607 | Tablets |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D044948 | Flavonols |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
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