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

Ain Shams University

Status and phase: Not yet enrolling; Phase 4

Conditions: Poly Cystic Ovary Syndrome

Treatments: Drug: Daflon; Drug: Metformin; Drug: Combined oral contraceptive

Study type: Interventional

Funder types: Other

Identifiers

NCT06083935

REC#166

Details and patient eligibility

About

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).

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Metformin + Combined oral contraceptive

Active Comparator group

Description:

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)

Treatment:

Drug: Combined oral contraceptive

Drug: Metformin

Diosmin /Hesperidin + Combined oral contraceptive

Experimental group

Description:

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)

Treatment:

Drug: Combined oral contraceptive

Drug: Daflon

Diosmin /Hesperidin +Metformin + Combined oral contraceptive combination

Active Comparator group

Description:

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

Treatment:

Drug: Combined oral contraceptive

Drug: Metformin

Drug: Daflon