Comparison of Myoinositol and Metformin in PCO
Λέξεις-κλειδιά
Αφηρημένη
Περιγραφή
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.
Ημερομηνίες
| Τελευταία επαλήθευση: | 11/30/2019 |
| Πρώτα υποβλήθηκε: | 10/21/2019 |
| Υποβλήθηκε εκτιμώμενη εγγραφή: | 12/16/2019 |
| Δημοσιεύτηκε για πρώτη φορά: | 12/17/2019 |
| Υποβλήθηκε τελευταία ενημέρωση: | 12/16/2019 |
| Δημοσιεύτηκε η τελευταία ενημέρωση: | 12/18/2019 |
| Ημερομηνία έναρξης της πραγματικής μελέτης: | 12/31/2019 |
| Εκτιμώμενη κύρια ημερομηνία ολοκλήρωσης: | 12/30/2020 |
| Εκτιμώμενη ημερομηνία ολοκλήρωσης μελέτης: | 02/24/2021 |
Κατάσταση ή ασθένεια
Παρέμβαση / θεραπεία
Drug: Metformin Hydrochloride
Drug: Myo-inositol
Φάση
Ομάδες βραχιόνων
| Μπράτσο | Παρέμβαση / θεραπεία |
|---|---|
| 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 |
Κριτήρια καταλληλότητας
| Επιλέξιμες ηλικίες για μελέτη | 16 Years Προς την 16 Years |
| Φύλα επιλέξιμα για μελέτη | Female |
| Δέχεται υγιείς εθελοντές | Ναί |
| Κριτήρια | 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 |
Αποτέλεσμα
Πρωτεύοντα αποτελέσματα
1. Menstrual cycle regulation [Follow up at 3rd and 6th months]
2. change in weight [Follow up at 3rd and 6th months]
Δευτερεύοντα αποτελέσματα
1. Pregnancy / Miscarriage [1 year]
