Impact of Adding Quercetin or Alpha Lipoic Acid as an Adjuvant Therapy on Clinical and Biochemical Outcomes in a Sample of Iraqi PCOS Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Hormonal Profile (LH, FSH, Testosterone) from Baseline
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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.
排除标准
- •• 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.
研究组 & 干预措施
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.
干预措施: Quercetin (Drug)
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.
干预措施: MetFORMIN 500 Mg Oral Tablet (Drug)
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.
干预措施: Alpha Lipoic Acid 600 MG Oral Tablet (Drug)
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.
干预措施: MetFORMIN 500 Mg Oral Tablet (Drug)
Control group
patients assigned to be treated with metformin 500 mg daily
干预措施: MetFORMIN 500 Mg Oral Tablet (Drug)
结局指标
主要结局
Change in Hormonal Profile (LH, FSH, Testosterone) from Baseline
时间窗: 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
时间窗: 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.
次要结局
- Change in Lipid Profile (Total Cholesterol, LDL-C, HDL-C, Triglycerides) from Baseline(Baseline and 3 months after starting assigned treatment)
- Change in Oxidative Stress and Related Biomarkers (Fibulin-1, Kisspeptin, SOD1, GPx) from Baseline(Baseline and 3 months after starting assigned treatment)
- Change in Quality of Life (PCOSQ Total Score) from Baseline(Baseline and 3 months after starting assigned treatment)
- Change in Medication Adherence (4-Item Morisky Scale Score) from Baseline(Baseline and 3 months after starting assigned treatment)
研究者
Mohammed Mahmood Mohammed
professor
Al-Mustansiriyah University