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Kisspeptin-10

KP-10, Metastin (45-54), Kisspeptin-10 (human), KiSS-1

Quick Stats
Studies 877
Trials 47
Recruiting PHASE2 INTERVENTIONAL NCT07182526

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

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.

Detailed Description

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

Interventions

Name: Quercetin
Type: DRUG
Description: Quercetin 500 mg capsule daily after meal for three months
Name: Alpha Lipoic Acid 600 MG Oral Tablet
Type: DRUG
Description: Alpha lipoic acid 600mg SR capsule daily after meal for three months period.
Name: MetFORMIN 500 Mg Oral Tablet
Type: DRUG
Description: metformin 500 mg daily for three months

Primary Outcomes

Measure: Change in Hormonal Profile (LH, FSH, Testosterone) from Baseline
TimeFrame: Baseline and 3 months after starting assigned treatment
Description: 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.
Measure: Change in Glycemic Control Markers (Fasting Glucose, Insulin, HOMA-IR) from Baseline
TimeFrame: Baseline and 3 months after starting assigned treatment
Description: 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.

Trial Information

NCT ID

NCT07182526

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Al-Mustansiriyah University

Last Updated

December 15, 2025