Poly Cystic Ovary Syndrome
Conditions
Brief 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).
Interventions
DRUGDaflon
Daflon; two film coated tablets 500 mg daily
Yassmin ® film-coated tablets 3 mg of drospirenone and 0.03 mg of ethinyl estradiol once daily daily
DRUGMetformin
Glucophage ® 500 tablets twice daily
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of the inflammation | 4 months | Improvement of PCOS status by improvement of the inflammatory markers (IL-6) |
| Improvement of glycemic index | 4 months | Improvement of glycemic index by measuring fasting Insulin, HOMA-IR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of PCOS status levels | 4 months | Improvement of PCOS status by improvement of signs and symptoms, hormone levels |
| Improvement of patient's quality of life | 4 months | Improvement of patient's quality of life by using the women health questionnaire (WHQ) |
Outcome results
None listed