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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-12-01

Brief Summary

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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).

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Detailed Description

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Conditions

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Poly Cystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Metformin + Combined oral contraceptive

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)

Group Type ACTIVE_COMPARATOR

Combined oral contraceptive

Intervention Type DRUG

Yassmin ® film-coated tablets 3 mg of drospirenone and 0.03 mg of ethinyl estradiol once daily daily

Metformin

Intervention Type DRUG

Glucophage ® 500 tablets twice daily

Diosmin /Hesperidin + 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)

Group Type EXPERIMENTAL

Daflon

Intervention Type DRUG

Daflon; two film coated tablets 500 mg daily

Combined oral contraceptive

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Daflon

Intervention Type DRUG

Daflon; two film coated tablets 500 mg daily

Combined oral contraceptive

Intervention Type DRUG

Yassmin ® film-coated tablets 3 mg of drospirenone and 0.03 mg of ethinyl estradiol once daily daily

Metformin

Intervention Type DRUG

Glucophage ® 500 tablets twice daily

Interventions

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Daflon

Daflon; two film coated tablets 500 mg daily

Intervention Type DRUG

Combined oral contraceptive

Yassmin ® film-coated tablets 3 mg of drospirenone and 0.03 mg of ethinyl estradiol once daily daily

Intervention Type DRUG

Metformin

Glucophage ® 500 tablets twice daily

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No