Effect of Diosmin/Hespiridin Combination on the Clinical Outcomes in Patients With Polycystic Ovary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Improvement of the inflammation
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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)
干预措施: Combined oral contraceptive (Drug)
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)
干预措施: Metformin (Drug)
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)
干预措施: Daflon (Drug)
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)
干预措施: Combined oral contraceptive (Drug)
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
干预措施: Daflon (Drug)
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
干预措施: Combined oral contraceptive (Drug)
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
干预措施: Metformin (Drug)
结局指标
主要结局
Improvement of the inflammation
时间窗: 4 months
Improvement of PCOS status by improvement of the inflammatory markers (IL-6)
Improvement of glycemic index
时间窗: 4 months
Improvement of glycemic index by measuring fasting Insulin, HOMA-IR
次要结局
- Improvement of patient's quality of life(4 months)
- Improvement of PCOS status levels(4 months)
研究者
Fatma Ahmed Tony
Assistant lecturer
Ain Shams University