跳至主要内容
临床试验/CTRI/2022/12/048046
CTRI/2022/12/048046尚未招募2 期

To compare the effectiveness of prescribed low carbohydrate diet versus balanced diet in the management of Polycystic Ovarian Syndrome-A randomised controlled clinical trial

Saraswati Kanase2 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2022年12月15日最近更新:

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.)

研究者

发起方
Saraswati Kanase
申办方类型
Other [self]

研究点 (2)

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