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Comparison of Myoinositol and Metformin in PCO

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala
Ingia / Ingia
Kiungo kimehifadhiwa kwenye clipboard
HaliBado kuajiri
Wadhamini
Rashid Latif Medical College

Maneno muhimu

Kikemikali

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.

Maelezo

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.

Tarehe

Imethibitishwa Mwisho: 11/30/2019
Iliyowasilishwa Kwanza: 10/21/2019
Uandikishaji uliokadiriwa Uliwasilishwa: 12/16/2019
Iliyotumwa Kwanza: 12/17/2019
Sasisho la Mwisho Liliwasilishwa: 12/16/2019
Sasisho la Mwisho Lilichapishwa: 12/18/2019
Tarehe halisi ya kuanza kwa masomo: 12/31/2019
Tarehe ya Kukamilisha Msingi iliyokadiriwa: 12/30/2020
Tarehe ya Kukamilisha Utafiti: 02/24/2021

Hali au ugonjwa

PCOS

Uingiliaji / matibabu

Drug: Metformin Hydrochloride

Drug: Myo-inositol

Awamu

-

Vikundi vya Arm

MkonoUingiliaji / matibabu
Experimental: 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
Experimental: 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
Experimental: 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

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza 16 Years Kwa 16 Years
Jinsia Inastahiki KujifunzaFemale
Hupokea Wajitolea wa AfyaNdio
Vigezo

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

Matokeo

Hatua za Matokeo ya Msingi

1. 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

2. 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

Hatua za Matokeo ya Sekondari

1. 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.

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