Impact of Flaxseed Lignan (Brevail) on Polycystic Ovarian Syndrome
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Primary outcomes to assess are the changes of testosterone levels and hirsutism.
研究概览
简要总结
PCOS is a disorder which is characterized by hyperandrogenism (high serum male hormone levels), ovulatory dysfunction, and polycystic ovaries (multiple follicles-over 12- in the ovary). There is no universally accepted definition for PCOS. The Rotterdam criteria require 2 of 3 criteria for diagnosis, including hyperandrogenism (clinical hirsutism or serum hormone measurement), oligomenorrhea/amenorrhea, and ultrasound findings of polycystic ovaries.
This study is a prospective randomized pilot study designed to evaluate the effects of flaxseed supplementation (with Brevail) on hormonal and lipid metabolism balance in polycystic ovarian syndrome (PCOS) patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Must be 18 to 40 year old female with:
- •Diagnosis of PCOS by menstrual irregularity (fewer than 9 menses annually/interval over 40 days), Ferriman-Galleway score >8, and/or hyperandrogenemia defined as total testosterone >80ng/dl or bioavailable testosterone >8.4 ng/dl.
- •Mentally competent.
排除标准
- •Use of oral contraceptives, spironolactone, or insulin-sensitizing agents within the past 2 months.
- •Long-term or chronic use of oral antibiotics.
- •Hysterectomy.
- •Pregnancy/lactation.
- •Consumption of flaxseed within the last month.
- •Diagnosis of thyroid disease, nonclassical adrenal hyperplasia, and hyperprolactinemia.
- •Use of any dietary fiber supplements which are newly started (within the past 6 months) and agreement not to use any new fiber supplements during the study period.
研究组 & 干预措施
Birth control
干预措施: Birth control (Drug)
Birth control plus Brevail
干预措施: Birth control plus Brevail (Drug)
结局指标
主要结局
Primary outcomes to assess are the changes of testosterone levels and hirsutism.
时间窗: up to 6 months
次要结局
- Secondary outcomes to assess are the lipid profile and estrogen levels.(Up to 6 months)