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临床试验/NCT02028702
NCT02028702已完成不适用

Alternative Treatments for Menopausal Women: The Efficacy of a Novel Red Clover Treatment on Menopausal Women.

Aarhus University Hospital2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2012年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
61
试验地点
2
主要终点
Primary Menopause-related symptoms

研究概览

简要总结

To investigate the reported health benefits (lipid profile, inflammatory factors, cardiovascular status and bone density) of a novel, phytoestrogen rich, Red Clover treatment on women suffering from both menopause related primary (hot flushes, night sweats, sleep disturbance and weight gain) and secondary (osteoporosis, cardiovascular and changes in lipid metabolism) symptoms.

详细描述

Menopausal symptoms are a common phenomenon causing discomfort to many middle aged women throughout the world. The core symptoms are experienced as hot flushes (HF), night sweats, vaginal dryness and sleep disturbance. Other secondary symptoms are sexual dysfunction, depression, anxiety, memory loss, fatigue, headache, joint pains and weight gain. Moreover there is increased risk of further complications such as osteoporosis, cardiovascular and negative changes in lipid profile associated with the reduction in oestrogen during and post menopause.

Trifolium Pratense or Red Clover (RC) has arisen as a popular source for women experiencing HF because it contains a variety of phytoestrogen's, namely isoflavones, lignans and coumestans. Phytoestrogens are shown to have positive effects on menopausal disorders such as breast cancer, cardiovascular risk factors, osteoporosis and have been shown to exert non-hormonal antioxidant effects. Additionally these isoflavones appear to reduce bone resorbtion, help maintain bone mineral density and improve lipid profile (reducing LDL: HDL, lipoprotein A, total cholesterol and may also reduce triglycerides).

RC is particularly high in estrogenic isoflavones biochanin A, formononetin and to a lesser degree genestein and diadzein, although the two former are precursors to genestein and diadzein. Asian populations with a high intake of soy (rich in genestein and diadzein) have long shown a lower reported incidence of the symptoms of menopause.

The study will be carried out as a 3-month parallel randomized control intervention study, consisting of 61 menopausal women. During summer 2012, 61 participants will be randomised into 2 groups (~30-31 in each group). The two groups are as follows:

  1. Menopausal women receiving RC treatment - 150ml/d Red Clover (80mg/d of isoflavones as aglycone)
  2. Menopausal women receiving placebo - 150ml placebo

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 40-65 years
  • Experiencing daily hot flushes
  • Body Mass Index (BMI) between 20-40
  • Irregular menstrual bleeding
  • FSH levels above the normal range

排除标准

  • Simultaneous participation in other clinical trials within the last 3 months
  • Severe cardiovascular, psychiatric, neurological, and/or kidney disease.
  • Alcohol or drug abuse and acute illness.
  • Blood pressure > 160/110
  • Pregnant and lactating women

结局指标

主要结局

Primary Menopause-related symptoms

时间窗: 3 months

To examine the extent to which red clover extract can reduce the frequency and intensity of hot flashes, sleep disturbances and flush related sweats.

次要结局

未报告次要终点

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Per Bendix Jeppesen

Associate Prof., PhD

Aarhus University Hospital

研究点 (2)

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