Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
126 participants
INTERVENTIONAL
2020-11-01
2021-07-25
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
Metformin Hydrochloride
Metformin Hydrochloride is used in PCO
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
Myo-inositol
Myo inositol used in PCO
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
Metformin Hydrochloride
Metformin Hydrochloride is used in PCO
Myo-inositol
Myo inositol used in PCO
Interventions
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Metformin Hydrochloride
Metformin Hydrochloride is used in PCO
Myo-inositol
Myo inositol used in PCO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
16 Years
35 Years
FEMALE
No
Sponsors
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Rashid Latif Medical College
OTHER
Responsible Party
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Lamia yusuf
Associate Professor
Principal Investigators
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LAMIA YUSUF, FCPS,MHPE
Role: PRINCIPAL_INVESTIGATOR
rlmc lahore
Locations
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Rashid Latif Medical College
Lahore, Punjab Province, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB/2019/027
Identifier Type: -
Identifier Source: org_study_id