Effect of Diosmin/Hespiridin Combination on the Clinical Outcomes in Patients With Polycystic Ovary Syndrome
| Registry | NCT06083935 |
|---|---|
| Status | Unknown |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 120 (Estimated) |
| Sponsor | Ain Shams University (Other) |
| Conditions | Poly Cystic Ovary Syndrome |
| Interventions | Daflon, Combined oral contraceptive, Metformin (Drug) |
| Dates | start 2023-11-01 (estimated), primary completion 2024-08-01 (estimated), completion 2024-12-01 (estimated), first posted 2023-10-16, last updated 2023-10-16 |
Related Papers Related Patents Related Grants Related Experts
All trials for Poly Cystic Ovary Syndrome All trials of Daflon All trials of Combined oral contraceptive
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Metformin + Combined oral contraceptive | Active comparator | Drug: Combined oral contraceptive; Drug: Metformin | Metformin (Glucophage ® 500 tablets twice daily)+ Combined oral contraceptive (standard therapy) (Yassmin ® film-coated tablets 3 mg of drospirenone and 0.03 mg of ethinyl estradiol once daily daily) |
| Diosmin /Hesperidin + Combined oral contraceptive | Experimental | Drug: Daflon; Drug: Combined oral contraceptive | Diosmin /Hesperidin (Daflon two tablets 500 mg daily)+ Combined oral contraceptive((Yassmin ® film-coated tablets 3 mg of drospirenone and 0.03 mg of ethinyl estradiol once daily daily) |
| Diosmin /Hesperidin +Metformin + Combined oral contraceptive combination | Active comparator | Drug: Daflon; Drug: Combined oral contraceptive; Drug: Metformin | Diosmin /Hesperidin (Daflon two tablets 500 mg daily) +Metformin (Glucophage ® 500 tablets twice daily) + Combined oral contraceptive combination (Yassmin ® film-coated tablets 3 mg of drospirenone and 0.03 mg of ethinyl estradiol once daily daily |
Sex: Female, ages: 18 Years to 40 Years
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