IMPACT OF NUTRITION INTERVENTION ON THE SYMPTOMS OF POLYCYSTIC OVARIAN SYNDROME AMONG WOMEN OF REPRODUCTIVE AGE (20- 45 YEARS)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- estimate the Impact of the formulated micronutrient rich powdered Formula on
研究概览
简要总结
Conduct of the study
Phase 1:
ï‚· Assessment of nutritional status using Anthropometric, Biochemical, Clinical and Diet history.
ï‚· Anthropometrics measurements Height, Weight, BMI, Waist Circumference, Hip circumference, Waist Hip Ratio (ICMR, 2010).
ï‚· Analysis of Biochemical Parameters .The following biochemical parameters are evaluated:
o Total serum testosterone
o Haemoglobin ( Hb)
o Lipid Profile
o Random Blood sugar
ï‚· Assessment of Clinical Parameters
o Hirsutism, Acne, Acanthosis Nigricans, Greasy skin, Alopecia
ï‚· Assessment of food and Nutrient Intake using Food diary ,3 day food record
Phase 2: Identification of Micronutrient rich food items and development of nutritional supplement and Evaluation of the supplement suitable for PCOS
| Ingredients Amount(gm) | |
| Pearl Millet 15 | |
| Finger Millet 10 | |
| Flax seeds 20 | |
| Pumpkin Seeds 20 | |
| Sesame seeds 15 | |
| Sunflower seeds 15 | |
| Brown Sugar 5 | |
| Total 100 |
Phase 3: Provide nutrition intervention using Standard Dietary intervention alone and with formulated supplement
Study Design:
Randomized Controlled Trial where patients will be assigned to the two groups described below using fish bowl technique
Group 1 – Nutrition Education
Group 2- Nutrition Education +Supplement
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •All women of reproductive age group (20-45 years), Screening for PCOS is done by using a validated Clinical Tool, Not taking any medication.
排除标准
- •Age less than 20 years and greater than 45 years, Other comorbidities, Concurrent treatment.
结局指标
主要结局
estimate the Impact of the formulated micronutrient rich powdered Formula on
时间窗: 12 weeks
Women of Reproductive age having Polycystic Ovarian Syndrome in terms of the
时间窗: 12 weeks
following: hormonal levels, metabolic features, clinical features, anthropometric measures
时间窗: 12 weeks
次要结局
- Study the etiological factors contributing to PCOS, Assessment of mental Health status, Assessment of physical activity level, Assessment of dietary pattern(3 months)