To compare the effectiveness of prescribed low carbohydrate diet versus balanced diet in the management of Polycystic Ovarian Syndrome-A randomised controlled clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Menstrual regularity (an initiation of menses or significant shortening of cycle length where possible 21-35 days menstrual cycle length
研究概览
简要总结
Polycystic Ovarian Syndrome is syndrome of endocrine, metabolic disorder of reproductive age, .Delay in diagnosis leads to many complications .Once a patient of PCOS always a patient through out life.Treatment of PCOS is symptomatic and its expensive. For menstrual irregularity and infertility with treatment also results doubtful .Menstrual regularity only till oral contraceptives are taken ,for infertility patient of PCOS may not conceive. with low carbohydrate diet and regular exercise menstrual regularity takes place,Improvement in hyperinsulinemia and hyperandrogenism also conception takes place .Life style modification is good option of treatment at low cost. So it should be first line of treatment of PCOS. In India very few randomised controlled trials of low carbohydrate diet .So taken randomised controlled trial of low carbohydrate diet against Balanced diet with patients of PCOS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)(—)
- 性别
- Female
入选标准
- •Diagnosed cases of Polycystic Ovarian Syndrome.
- •Polycystic Ovarian Syndrome patients not taking oral contraceptives for > 4 weeks.
- •Hormone treatment or insulin sensitizing agents >2weeks.
- •Patients willing to participate in study.
排除标准
- •Patients of PCOS who are pregnant.
- •Patients of PCOS who are lactating.
- •Patients with existing psychiatric disorders like depression, schizophrenia, anxiety, obsessive conditions, insomnia.
- •Patients with Prolactinoma, Hypothyroidism.
结局指标
主要结局
Menstrual regularity (an initiation of menses or significant shortening of cycle length where possible 21-35 days menstrual cycle length
时间窗: 21-35 days menstrual cycle length
次要结局
- Weight loss(Laboratory values -Fasting (12Hr)Insulin,fasting sugar,lipid profile.)
