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Trial Title:
Evaluation of the Effects of Diosmin/Hespiridin Combination on the Clinical Outcomes in Patients With Polycystic Ovary Syndrome
NCT ID:
NCT06083935
Condition:
Poly Cystic Ovary Syndrome
Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome
Metformin
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Care Provider)
Intervention:
Intervention type:
Drug
Intervention name:
Daflon
Description:
Daflon; two film coated tablets 500 mg daily
Arm group label:
Diosmin /Hesperidin + Combined oral contraceptive
Arm group label:
Diosmin /Hesperidin +Metformin + Combined oral contraceptive combination
Intervention type:
Drug
Intervention name:
Combined oral contraceptive
Description:
Yassmin ® film-coated tablets 3 mg of drospirenone and 0.03 mg of ethinyl estradiol once
daily daily
Arm group label:
Diosmin /Hesperidin + Combined oral contraceptive
Arm group label:
Diosmin /Hesperidin +Metformin + Combined oral contraceptive combination
Arm group label:
Metformin + Combined oral contraceptive
Intervention type:
Drug
Intervention name:
Metformin
Description:
Glucophage ® 500 tablets twice daily
Arm group label:
Diosmin /Hesperidin +Metformin + Combined oral contraceptive combination
Arm group label:
Metformin + Combined oral contraceptive
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).
Criteria for eligibility:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
40 Years
Healthy volunteers:
No
Start date:
November 1, 2023
Completion date:
December 1, 2024
Lead sponsor:
Agency:
Ain Shams University
Agency class:
Other
Source:
Ain Shams University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06083935
