Comparison of Myoinositol and Metformin in PCO

Study Overview
=================
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.

Official Title
-----------------
A Comparative Study of Myo Inositol and Metformin in Improving Biochemical and Clinical Profile of Patients With Polycystic Ovarian Syndrome; a Randomized Clinical Trial

Conditions
-----------------
PCOS

Intervention / Treatment
-----------------
* Drug: Metformin Hydrochloride
* Drug: Myo-inositol


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: GROUP A ( Metformin 500 mg TDS), GROUP B( Myoinositol 2000 mg x BD ), GROUP C.(both metformin,& myoinositol)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GROUP A ( metformin 500 mg TDS)<br>Life style modifications, Weight reduction and folic acid will be prescribed with metformin 500 mg three times a day | Drug: Metformin Hydrochloride<br>* Metformin Hydrochloride is used in PCO<br>* Other names: Folic acid;|
| Experimental: GROUP B( myoinositol 2000mg x BD )<br>Life style modifications, Weight reduction and folic acid will be prescribed with myoinositol 2000 mg two times a day | Drug: Myo-inositol<br>* Myo inositol used in PCO<br>* Other names: Folic Acid;|
| Experimental: GROUP C.(both metformin,& myoinositol)<br>Life style modifications, Weight reduction and folic acid will be prescribed with both metformin,& myoinositol three and two times a day respectively | Drug: Metformin Hydrochloride<br>* Metformin Hydrochloride is used in PCO<br>* Other names: Folic acid;Drug: Myo-inositol<br>* Myo inositol used in PCO<br>* Other names: Folic Acid;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menstrual cycle regulation | 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 | Follow up at 3rd and 6th months | 
| change in weight | 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 | Follow up at 3rd and 6th months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy / Miscarriage | The secondary outcome measured will be the rate of conception/pregnancy, miscarriage and term pregnancy among these patients inducted in the study. | 1 year |