Comparison of Myoinositol and Metformin in PCO
Từ khóa
trừu tượng
Sự miêu tả
PCOS is a common endocrine disorder in women of reproductive age associated with insulin resistance. Metformin and Myo-inositol being insulin sensitizers improve biochemical parameters. it is aimed to compare the effect of myoinositol and metformin in the resumption of the spontaneous menstrual cycle in patients diagnosed with PCOS or having oligo/amenorrhea, reduction in weight and BMI, Improvement in the biochemical and clinical profile of patients with the polycystic syndrome.
Inclusion criteria: will be based on the Rotterdam criteria of diagnosing PCO. Patients presenting with a history of secondary amenorrhea, irregular menstrual cycle, oligomenorrhea, weight gain, hirsutism, and already diagnosed cases of PCO will be included in this group.
Patients with history of Hyperprolactinemia, Cushing's disease, Hypothyroidism/ Hyperthyroidism, Pregnancy and nursing, Established type 1 or type 2 diabetes mellitus, Any history of drug intake e.g. anti-diabetic or estrogen and progesterone, History of treatment for the same complaint taken in the last 3 months, Unable to come for regular follow-ups, Any pathological cause of bleeding e.g. Fibroid, Polyp, Cervical pathology and known allergic to these drugs would be excluded.
ngày
| Xác minh lần cuối: | 11/30/2019 |
| Đệ trình đầu tiên: | 10/21/2019 |
| Đăng ký ước tính đã được gửi: | 12/16/2019 |
| Đăng lần đầu: | 12/17/2019 |
| Cập nhật lần cuối được gửi: | 12/16/2019 |
| Cập nhật lần cuối đã đăng: | 12/18/2019 |
| Ngày bắt đầu nghiên cứu thực tế: | 12/31/2019 |
| Ngày hoàn thành chính ước tính: | 12/30/2020 |
| Ngày hoàn thành nghiên cứu ước tính: | 02/24/2021 |
Tình trạng hoặc bệnh tật
Can thiệp / điều trị
Drug: Metformin Hydrochloride
Drug: Myo-inositol
Giai đoạn
Nhóm cánh tay
| Cánh tay | Can thiệp / điều trị |
|---|---|
| Experimental: GROUP A ( metformin 500 mg TDS) Life style modifications, Weight reduction and folic acid will be prescribed with metformin 500 mg three times a day | |
| Experimental: GROUP B( myoinositol 2000mg x BD ) Life style modifications, Weight reduction and folic acid will be prescribed with myoinositol 2000 mg two times a day | |
| Experimental: GROUP C.(both metformin,& myoinositol) Life style modifications, Weight reduction and folic acid will be prescribed with both metformin,& myoinositol three and two times a day respectively |
Đủ tiêu chuẩn
| Tuổi đủ điều kiện để học | 16 Years Đến 16 Years |
| Giới tính đủ điều kiện để nghiên cứu | Female |
| Chấp nhận tình nguyện viên lành mạnh | Đúng |
| Tiêu chí | Inclusion Criteria: It will be based on the Rotterdam criteria of diagnosing PCO. Patients presenting with a history of secondary amenorrhea, irregular menstrual cycle, oligomenorrhea, weight gain, hirsutism, and already diagnosed cases of PCO will be included in this group. Exclusion Criteria: - Hyperprolactinemia - Cushing's disease - Hypothyroidism/ Hyperthyroidism - Pregnancy and nursing - Established type 1 or type 2 diabetes mellitus - Any history of drug intake e.g. anti-diabetic or estrogen and progesterone - History of treatment for the same complaint taken in the last 3 months - Unable to come for regular follow-ups - Any pathological cause of bleeding e.g. Fibroid, Polyp, Cervical pathology - Known allergic to these drugs |
Kết quả
Các biện pháp kết quả chính
1. Menstrual cycle regulation [Follow up at 3rd and 6th months]
2. change in weight [Follow up at 3rd and 6th months]
Các biện pháp kết quả thứ cấp
1. Pregnancy / Miscarriage [1 year]
