PCOS
Conditions
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.
Interventions
DRUGMetformin Hydrochloride
Metformin Hydrochloride is used in PCO
DRUGMyo-inositol
Myo inositol used in PCO
Sponsors
Rashid Latif Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Treatment will be assigned to each participant using lottery method
Intervention model description
GROUP A ( Metformin 500 mg TDS), GROUP B( Myoinositol 2000 mg x BD ), GROUP C.(both metformin,& myoinositol)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Pakistan
Contacts
Primary ContactLAMIA YUSUF, FCPS,MHPE
Backup ContactArslan Saleem, Masters
Outcome results
None listed