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Идёт набор NCT07182526

Effects of Adding Quercetin or Alpha Lipoic Acid to Usual Care on Symptoms and Blood Markers in Iraqi Women With Polycystic Ovary Syndrome

Фаза II С лечением PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Quercetin, Alpha Lipoic Acid 600 MG Oral Tablet, MetFORMIN 500 Mg Oral Tablet.
Кому может быть актуально
Состояния в реестре: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Ирак
Следующий шаг
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Официальное название

Impact of Adding Quercetin or Alpha Lipoic Acid as an Adjuvant Therapy on Clinical and Biochemical Outcomes in a Sample of Iraqi PCOS Patients

Обзор

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.

Подробное описание

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

Вмешательства

  • Препарат Quercetin
    Quercetin 500 mg capsule daily after meal for three months
  • Препарат Alpha Lipoic Acid 600 MG Oral Tablet
    Alpha lipoic acid 600mg SR capsule daily after meal for three months period.
  • Препарат MetFORMIN 500 Mg Oral Tablet
    metformin 500 mg daily for three months

Первичные конечные точки

  • Change in Hormonal Profile (LH, FSH, Testosterone) from Baseline [Срок оценки: Baseline and 3 months after starting assigned treatment]
  • Change in Glycemic Control Markers (Fasting Glucose, Insulin, HOMA-IR) from Baseline [Срок оценки: Baseline and 3 months after starting assigned treatment]
Вторичные конечные точки (4)
  • Change in Lipid Profile (Total Cholesterol, LDL-C, HDL-C, Triglycerides) from Baseline [Срок оценки: Baseline and 3 months after starting assigned treatment]
  • Change in Oxidative Stress and Related Biomarkers (Fibulin-1, Kisspeptin, SOD1, GPx) from Baseline [Срок оценки: Baseline and 3 months after starting assigned treatment]
  • Change in Quality of Life (PCOSQ Total Score) from Baseline [Срок оценки: Baseline and 3 months after starting assigned treatment]
  • Change in Medication Adherence (4-Item Morisky Scale Score) from Baseline [Срок оценки: Baseline and 3 months after starting assigned treatment]

Критерии участия

Критерии включения

  • • 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.

Критерии исключения

  • • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Ирак · 1 центр
  • Mustansiriyah University/ College of Pharmacy — Baghdad

Идентификаторы

NCT: NCT07182526 · Mustansiriyah University/ 85

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗