Soy Isoflavonates Versus Placebo on Quality of Life in Menopausal Women: Randomized Double-blind Clinical Trial: FLAVOCAV TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- MENCAV
研究概览
简要总结
Within the context of the proposed research study, the effect of soy isoflavonoid supplements on the quality of life and coagulation of menopausal women. It has been observed that menopause, as a physiological process, is associated with alterations in the physical, mental and sexual quality of life, making the use of hormone replacement therapy necessary; however, hormone therapy is associated with hypercoagulability, since it has been seen that women have higher levels of thrombogenic microvesicles such as: platelets with a greater probability of causing blood clotting were more likely to present a greater amount of white matter hyperintensities, which appear in the MRI scan.
详细描述
The following study is aimed at clarifying the effects of soy isoflavonate supplements on the quality of life and markers of hypercoagulability in menopausal women. The reasons for conducting this research arise from the concern of minimizing side effects such as hypercoagulation caused by hormone replacement therapy, which is intended to be replaced with soy isoflavonates to evaluate its efficacy.
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 (Participant, Investigator)
盲法说明
To eliminate researcher bias, a third research participant will place the capsules containing the soy isoflavonate in one bottle and the placebo in another bottle. The bottles will be labeled as group A and group B, but the researchers will not know which is in which group, to ensure that the study intervention and the control/placebo are as indistinguishable as possible to the participants.
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
- 是
入选标准
- •Submission of a signed and dated informed consent form.
- •Declared willingness to comply with all study procedures and availability for the duration of the study.
- •Can read and write
- •Female, age 45 to 65 years
- •Female with more than 1 year of amenorrhea.
- •No hormone replacement therapy or herbal medications in the 6 months prior to the investigation.
- •Ability to take oral medication and willing to comply with the <study intervention regimen.
- •Agreement to comply with Lifestyle Considerations for the duration of the study.
- •Have a smartphone-type cell phone
- •Residence in Francisco Morazán
排除标准
- •Patient does not sign informed consent
- •Patient does not wish to participate
- •History of thrombo embolism
- •History of cardiovascular disease
- •Presence of estrogen-dependent neoplasm
- •Presence of abnormal genital bleeding
- •Uncontrolled metabolic diseases
- •Smoking and drinking habits
- •Use of anticoagulant or acetylsalicylic acid
- •Known allergic reactions to soy isoflavonate components
- •History of thrombophilias such as: Antithrombin deficiency, Protein C deficiency, Protein S deficiency, Factor V Leiden, Prothrombin G20210A, Hyperhomocysteinemia, Antiphospholipid syndrome, Acquired activated protein C resistance.
结局指标
主要结局
MENCAV
时间窗: One month from the first intervention until 6 months
Change in MENCAV questionnaire scores, with 37 items likert type scale, the lowest point is zero and the maximun is 259 points
次要结局
- D-dimer(One month from the first intervention until 6 months)
- side effects(One month from the first intervention until 6 months)
研究者
Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
Titular professor
Universidad Nacional Autonoma de Honduras