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临床试验/NCT00179556
NCT00179556已完成2 期

Daidzein-rich Isoflavone-aglycones for Menopausal Symptoms

Beth Israel Deaconess Medical Center2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2003年6月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
210
试验地点
2
主要终点
Hot flash frequency and severity

研究概览

简要总结

Hot flashes occur in three quarters of menopausal women, and can negatively impact quality of life. Interest has arisen in isoflavones, found in rich supply in soy products, as therapy for hot flashes. The study examines the effect of a new soy supplement, as compared to a placebo, in menopausal women on hot flash symptoms.

详细描述

Hot flashes occur in 75% of menopausal women and impact quality of life. Interest has arisen in isoflavones, found in rich supply in soy products, as therapy for hot flashes. The effect of a daidzein-rich isoflavone-aglycone supplement from soy germ fermentation with Koji fungus, on the severity and frequency of hot flashes in postmenopausal women is being examined in a randomized, placebo controlled, double-blinded clinical trial. The study is a 13 week trial in which subjects record their hot flash frequency and severity in a diary. Subjects are given 40 mg or 60 mg of isoflavones (or placebo) once a day. This isoflavone-aglycone extract (Agly-Max TM, Nichimo, Shinagawa, Tokyo, Japan) is a product prepared from soybean germ fermentation with Koji fungus (Aspergliius awamori) producing ß-glycosidase efficiency, followed by ethanol and water extraction and purification by using a proprietary extraction procedure. The product is rich in daidzein (70% daidzein, 10% genistein, and 20% glycitein).

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
Double

入排标准

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

入选标准

  • No menstrual period for at least six months, Hot flashes at least four t imes per day, Ages 38-65

排除标准

  • Pregnant, BMI>45, History of breast cancer or other estrogen dependent tumors, Abnormal uterine bleeding, Heart, renal, or liver disease, Diabetes, Women taking hormone replacement therapy or serotonin reuptake inhibitors, Women taking any dietary supplements for the treatment of hot flashes (ex. soy supplements, vitamin E, flaxseed, red clover extract) within the past 30 days

结局指标

主要结局

Hot flash frequency and severity

次要结局

  • Menopausal quality of life

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hope Ricciotti

Associate Professor of Obstetrics, Gynecology and Reproductive Biology

Beth Israel Deaconess Medical Center

研究点 (2)

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