Study to Evaluate the Changes in Quality of Life in Menopausal Women After the Administration of Soy Isoflavones Combined With Magnolia Extract
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- the quality of life measured by the scale of Cervantes
研究概览
简要总结
In menopause, the vasomotor symptomatology, accompanied or less by affective and behavioural symptoms, globally worsens the quality of daily life.
The improvement of the quality could be reached with adequate food supplements, named phytoestrogens, in particular Soy Isoflavones (SI), which are natural substances with estrogen-like and estrogen-antagonistic activity, which are active in the control of menopausal vasomotor symptoms. Besides, combined with magnolia extract it could improve the psychological symptomatology also improving the quality of life.
详细描述
Multicenter, observational, prospective, longitudinal study of clinical practice conducted in 10 gynecological centers.
The study will be conducted in patients with typical mild to moderate vasomotor symptoms and psycho symptoms such as mood disorders, or sleep, anxiety / depression, which do not require specific drug treatment.
Quality of life will be analyzed by the scale of Cervantes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with at least 12 months of amenorrhea
- •Presence of 1 or more vasomotor symptoms as hot flushing, nocturnal sweating or palpitations
- •One or more psychological symptoms as insomnia, irritability, anxiety, depressed mood. Also with concomitant symptoms of sexual area as reduction of libido and vaginal dryness.
- •Women must give the informed consent
排除标准
- •clinical history of medical or surgical pathologies that could affect the results of the study, including serious cardiovascular, metabolic, kidney or liver diseases
- •Patients with the habit of eating soy foods or dietary supplements with soy extract
- •patients diagnosed with breast or uterine mass (neoplasia hormone sensitive)
- •patients that were treated with estrogens (HRT or phytoestrogens)in the 2 months before the beginning of the study.
- •patients with treatment with antibiotics, antidepressant and/or anxiolytic products
结局指标
主要结局
the quality of life measured by the scale of Cervantes
时间窗: baseline and 12 weeks
The Cervantes scale is a Spanish validated questionnaire specific for measure the quality of life in menopausal women
次要结局
- Clinical changes in vasomotor symptomatology(baseline, 2, 4, 8 and 12 weeks)