drugset / Trial / NCT06083935

Evaluation of the Effects of Diosmin/Hespiridin Combination on the Clinical Outcomes in Patients With Polycystic Ovary Syndrome

NCT06083935

Phase 4 Unknown 120 enrolled Ain Shams University
RandomizedParallel-groupDouble-blindTreatment

Summary

Polycystic ovary syndrome (PCOS) is one of the most prevalent disorders worldwide. Insulin resistance, inflammation and disturbance in sex hormone levels are the main contributing factors of this disease.The majority of studies addressing the status of chronic low-grade inflammation in PCOS have focused on the measurement of C-reactive protein (CRP) followed by stimulation of interleukin 6 (IL-6) and tumor necrosis factor (TNF-alpha). Daflon 500 mg tablets (containing 90% of diosmin and 10% of hesperidin) is used in patients to treat varicose veins, venous ulcers, hemorrhoids and lymphatic insufficiency. It has anti-diabetic, anti-inflammatory, microcirculatory, and antioxidant effects. So the aim of the work is to investigate the effect of Diosmin/Hesperidin in the management of PCOS through evaluation of Oxidative stress and inflammation, improvement of signs and symptoms through patients' follow-up, improvement of PCOS status by sonography and hormonal levels, measuring of anti-diabetic effect by measuring, fasting insulin, HOMA-IR and measuring the improvement of patient's quality of life by using the women health questionnaire (WHQ).

Timeline

Start
2023-11-01
Primary completion
2024-08-01
Completion
2024-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Diosmin/Hesperidin Unknown 500 mg
Comparator Metformin Small molecule 500 mg
Background drospirenone Unknown 3 mg
Background ethinyl estradiol Small molecule 0.03 mg