Comparison of Myoinositol and Metformin in PCO
- Registration Number
- NCT04204044
- Lead Sponsor
- Rashid Latif Medical College
- Brief Summary
Aim of the study is 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.
The secondary outcome measured will be the rate of pregnancy, miscarriage and term pregnancy among these patients inducted in the study.
It will be a Three-arm prospective double-blind study. this clinical trial will be registered in Public registry. this RCT will be based on CONSORT statement. The patient coming to Gynecology OPD will be randomized into 3 groups GROUP A ( metformin 500 mg TDS), GROUP B( myoinositol 2mg x BD ), GROUP C.(both metformin,\& myoinositol).each group will take folic acid and will be asked for lifestyle modifications.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 126
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GROUP B( myoinositol 2000mg x BD ) Myo-inositol Life style modifications, Weight reduction and folic acid will be prescribed with myoinositol 2000 mg two times a day GROUP A ( metformin 500 mg TDS) Metformin Hydrochloride Life style modifications, Weight reduction and folic acid will be prescribed with metformin 500 mg three times a day GROUP C.(both metformin,& myoinositol) Metformin Hydrochloride Life style modifications, Weight reduction and folic acid will be prescribed with both metformin,\& myoinositol three and two times a day respectively GROUP C.(both metformin,& myoinositol) Myo-inositol Life style modifications, Weight reduction and folic acid will be prescribed with both metformin,\& myoinositol three and two times a day respectively
- Primary Outcome Measures
Name Time Method Menstrual cycle regulation Follow up at 3rd and 6th months In the resumption of the spontaneous menstrual cycle in patients diagnosed with PCOS or having oligo/amenorrhea.Improvement in the biochemical and clinical profile of patients with the polycystic syndrome
change in weight Follow up at 3rd and 6th months change in weight and BMI. Weight in Kg(s) and height will be measured in meter(s). BMI will be calculated by dividing weight in Kg with height in meter square
- Secondary Outcome Measures
Name Time Method Pregnancy / Miscarriage 1 year The secondary outcome measured will be the rate of conception/pregnancy, miscarriage and term pregnancy among these patients inducted in the study.
Trial Locations
- Locations (1)
Rashid Latif Medical College
🇵🇰Lahore, Punjab, Pakistan