Therapeutic Role of Flax Seed for Poly Cystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Leutinizing Hormone (mIU/MI)
研究概览
简要总结
The study was conducted to determine the therapeutic role of flax seed for Poly cystic ovary syndrome. A sample of 100 subjects were collected. The subjects were from various age group ranging from 18 to 45 years. Subjects showing the signs, symptoms, biochemical, and clinical parameters of the diseases were included in the study. Three different quantities of flax seed were introduced to the subjects for 90 days.
Objectives:
- To assess the nutritional status of Poly cystic Ovary Syndrome patients
- To determine the therapeutic role of flax seed for PCOS patients
Material and method: The level of follicle stimulating hormone, leutinizing hormone, sex hormone binding globulin, serum prolactin, ultrasound were analyzed. To determine the side effects of the flax seed, the liver-enzymatic, lipid profile, and renal tests were conducted.
详细描述
Material and methods
Study Population:
The data were collected from the Allied Hospital. All Females of ages 18 to 45 years, having PCOS attending the OPD of Allied Hospital was taken as the study population. Efficacy trials were conducted on the patients of PCOS, including females of age 18-45 years. They were divided into different groups (as per no. of selected treatments along with the control). Ten subjects left the study and were replaced. The project was approved by the ethical review committee.The feeding study was conducted with the cooperation of Allied Hospital. The study protocol was discussed with medical professionals and finalized after through technical suggestions.
Selection of subjects and Study Design
The patients were assorted randomly into four groups, 25 in each, namely control (T0),
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
- Single (Participant)
盲法说明
Single-blinded trial, Intervention and placebo given
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• All females of age 18 to 45 having PCOS
- •Women showing the presence of two out of three features (Oligo- or anovulation, hyper-androgenism, or polycystic ovaries (Ovarian volume >10cc, 12 or more peripherally located follicles 2-9 mm in diameter or hypo-echoic enlarged ovaries with hyper-echoic central stroma in USG)
- •Patients on Metformin (used for insulin resistance)
排除标准
- •• Females under 18 and above 45 years of age
- •Those on any other medical therapy
- •Pregnant and lactating women
- •Those with a history of allergy to flaxseed
- •Women on antiplatelet and fibrinolytic drugs
- •Women showing signs of PCOS but showing normal ovaries on ultrasound
结局指标
主要结局
Leutinizing Hormone (mIU/MI)
时间窗: 3 months
The blood sample was taken to determine the quantitative level of serum luteinizing hormone (LH) in patients fed with flaxseed powder by following the Immuno-enzymatic calorimetric method (ELISA-ALPCO)
Sex hormone binding globulin (mg/dL)
时间窗: 3 months
The serum sex hormone binding globulin hormone (SHBG) in patients fed with flaxseed powder was determined by following the Rosner's method.
Serum Prolactin (ng/ml)
时间窗: 3 months
The serum sex prolactin level in patients fed with flaxseed powder was determined by following the radio-immunological method.
Follicle stimulating hormone (mIU/MI)
时间窗: 3 months
The blood sample was taken to determine the quantitative level of serum follicles stimulating hormone (FSH) in patients fed with flaxseed powder by following the Immuno-enzymatic calorimetric method (ELISA).
次要结局
- blood sugar fasting (mg/dL)(3 months)
- Thyroid stimulating hormone (Ml/L)(3 months)
研究者
Farhat Younas
Clinical Nutritionist
Allied Hospital Faisalabad