Comparison of Myoinositol and Metformin in PCO

• Status: Not yet recruiting
• Trial end date: 2021-07-25
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rashid Latif Medical College
• Treatments: Folic Acid; Inositol; Metformin; Vitamin B Complex

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