To Analyse the effectiveness of Low carbohydrate diet intervention among women diagnosed with Polycystic Ovary Syndrome A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Primary Outcomes will be Change in the weight and BMI
研究概览
简要总结
This will be a randomized controlled trial to analyse the effectiveness of Low Carbohydrate diet in comparison with Standard South Indian Diet in the management of women in the age group of 18-45 years of age with Polycystic Ovary Syndrome. The composition of Low Carbohydrate Diet will be as per the recommendations of an expert panel set up specifically to recommend a suitable diet. The Primary outcomes will be change in weight and regulation of menstrual cycles indicating resumption of normal ovulation. Secondary outcomes will look at improvement in metabolic and hormonal parameters and fertility parameters in those who are anxious to conceive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women in the age group 18-45 years of age diagnosed with PCOS as per Rotterdam Criteria Attending the outpatient clinic during the study period.
排除标准
- •Diabetes Mellitus Chronic Hypertension Cardiovascular Diseases Endometriosis Patients on drugs which affect the observation.
结局指标
主要结局
Primary Outcomes will be Change in the weight and BMI
时间窗: 3 to 6 months
and Regularity of menstrual cycles (Assessed by Self Reported Charting)
时间窗: 3 to 6 months
次要结局
- SECONDARY OUTCOMES will be Changes in Glycaemic control parameters including Fasting Blood Sugars & Glycated Haemoglobin (HbA1C), Changes in serum lipid profile (Total Cholesterol, Serum Triglycerides, Low Density Lipoproteins, Very Low Density Lipoproteins & High Density Lipoproteins levels), Changes in Insulin resistance parameters, Changes in Liver Function Tests, Changes in ovarian morphology as assessed by Ultrasonography, Changes in androgenic features of PCOS including facial hair growth & Fertility outcomes among married women & those who are anxious to conceive
研究者
ArunachalamR
Government Mohan Kumaramangalam Medical College Hospital, Salem, Tamilnadu, India.