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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin + Combined oral contraceptive | Active Comparator | 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 | 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 | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daflon | Drug | Daflon; two film coated tablets 500 mg daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of the inflammation | Improvement of PCOS status by improvement of the inflammatory markers (IL-6) | 4 months |
| Improvement of glycemic index | Improvement of glycemic index by measuring fasting Insulin, HOMA-IR | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of PCOS status levels | Improvement of PCOS status by improvement of signs and symptoms, hormone levels | 4 months |
| Improvement of patient's quality of life | Improvement of patient's quality of life by using the women health questionnaire (WHQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D004145 | Diosmin |
| D003277 | Contraceptives, Oral, Combined |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D047309 | Flavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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| Combined oral contraceptive | Drug | Yassmin ® film-coated tablets 3 mg of drospirenone and 0.03 mg of ethinyl estradiol once daily daily |
|
| Metformin | Drug | Glucophage ® 500 tablets twice daily |
|
| 4 months |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D003276 | Contraceptives, Oral |
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |