Study on the Effect of a Nutritional Supplement With Isoflavones on the Symptoms of Climacteric in Healthy Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Change from Baseline to Week 8 in the global score of quality of life using the validated Cervantes Scale
研究概览
简要总结
This study was designed to evaluate the beneficial effects and safety of a standardised botanical extract combination containing soy isoflavone extract, grains of paradise seed dry extract and pomegranate skin dry extract on health-related Quality of Life in healthy Spanish menopausal women with hot flashes, anxiety, and depressive symptoms using the self reported and validated Cervantes Scale.
详细描述
Fifty-seven outpatient women (45-65 years) with menstrual problems associated with climacteric syndrome were enrolled from April 2018 to April 2019 in the context of a prospective, placebo-controlled, double-blind study. Women were randomized to receive treatment with either the botanical combination (250 mg daily divided into two doses) or placebo for eight weeks. At the beginning and end of the study, health-related Quality of Life was assessed using the Cervantes Scale.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women in the Climacteric Phase under medical criteria based on Health questionnaire, Blood and urine test.
- •Informed consent to participate in the study.
排除标准
- •Hormone-related pathologies.
- •Menopause from surgery origin.
- •Family or personal history of endocrine cancer.
- •Known hypersensitivity to gluten, soybeans, soy protein, dairy products, pomegranate or grains of paradise.
- •Vegetarian diet or daily consumption of soya rich-products during the last year.
- •Anovulatory treatment.
- •Hormone replacement treatment.
结局指标
主要结局
Change from Baseline to Week 8 in the global score of quality of life using the validated Cervantes Scale
时间窗: 8 weeks
To evaluate the improvement of quality of life after trial, a variable to quantify the percentage of reduction between after-treatment and before-treatment for global score (GS) in quality of life is generated: \[Variation%=100 x ((initial GS value-final GS value)/ initial GS value)\]
次要结局
- Change from Baseline to Week 8 in the Menopause-health score of quality of life using the validated Cervantes Scale(8 weeks)
- Change from Baseline to Week 8 in the psychic score of quality of life using the validated Cervantes Scale(8 weeks)
- Change from Baseline to Week 8 in the sexuality-couple score of quality of life using the validated Cervantes Scale.(8 weeks)