A Comparative Study of Myo Inositol and Metformin in Improving Biochemical and Clinical Profile of Patients With Polycystic Ovarian Syndrome; a Randomized Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Menstrual cycle regulation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Treatment will be assigned to each participant using lottery method
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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
干预措施: Metformin Hydrochloride (Drug)
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
干预措施: Myo-inositol (Drug)
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
干预措施: Metformin Hydrochloride (Drug)
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
干预措施: Myo-inositol (Drug)
结局指标
主要结局
Menstrual cycle regulation
时间窗: 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
时间窗: 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
次要结局
- Pregnancy / Miscarriage(1 year)
研究者
Lamia yusuf
Associate Professor
Rashid Latif Medical College