Overview

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

Status:
Not yet recruiting
Trial end date:
2024-12-01
Target enrollment:
0
Participant gender:
Female
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ain Shams University
Treatments:
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Metformin
Criteria
Inclusion Criteria:

- Patients with confirmed diagnosis of PCOS aged in the range from18-40 (premenopausal
adults) diagnosed with PCOS according to Rotterdam criteria by an expert gynecologist;
(1) oligo-ovulation and/or anovulation (2) Clinical and biochemical hyperandrogenism
and (3) polycystic ovaries on ultrasonography

Exclusion Criteria:

- 1-Pregnant and nursing women 2-Menopause women 3-Diabetic patients 4-Adrenal
hyperplasia 5-Adrenal Tumor 6-Thyroid dysfunction 7-Women on confounding medications
which affect ovarian function