Observational Study to Evaluate the Quality of Life of Healthy Postmenopausal Women Who Take Coenzyme Q-Ubiquinol
2018年5月10日 更新者：Dr. Santiago Palacios
Observational Study With Food Product to Evaluate the Quality of Life of Healthy Postmenopausal Women Who Take Coenzyme Q-Ubiquinol, Compared With Another Group of the Same Age That Does Not Take coenzymeQ-Ubiquinol
Observational study about quality of life in postmenopausal women taking coenzyme Q compared to another group of women of the same age who do not take it
研究概览
详细说明
Observational study to evaluate the subjective assessment performed by healthy postmenopausal women who are taking coenzyme Q for 3 months, compared with other groups of the same characteristics that do not take it
研究类型
观察性的
注册 (实际的)
40
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Madrid、西班牙、28009
- Instituto Palacios
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不适用
取样方法
非概率样本
研究人群
Healthy postmenopausal woman between 45 and 65 years
描述
Inclusion Criteria:
- Postmenopausal woman between 45 and 65 years old
- Woman who is taking coenzyme Q-Ubiquinol and who will continue taking at least the next 3 months
- Woman not taking Coenzyme Q-Ubiquinol and not going to take it in the next 3 months
Exclusión Criteria:
- Patients with severe mental illness.
- Suspicion or abuse of alcohol or other drugs during the 12 months prior to the selection
- Any other consideration or finding that, in the opinion of the investigator, considers the non-participation of the subject in the study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Active Group
Women who are taking coenzyme Q and who will continue taking it for 3 months
|
Patients in the active group will take one tablet a day orally
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|
Control Group
Women who are not taking coenzyme Q and who will not take it in the next 3 months
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline Quality of Life at 3 months
大体时间：Baseline and 3 months
|
To evaluate the quality of life in healthy postmenopausal women who are taking Coenzyme Q-Ubiquinol for 3 months in comparison with another group that does not take them.
The Cervantes Health-Related Quality of Life scale for menopause will be used for this outcome.
In that scale next to the 0 and the 5 there are words that describe two opposite answers to the question.
Between the 0 and the 5 there are also four boxes numbered 1 to 4. The participants should answer the questions by checking the box that best represents what they think and feel.
In other words, they should check 5 if they are completely agree and 0 they are completely disagree.
If they are not completely agree or disagree, they should check the boxes in between
|
Baseline and 3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline General Health at 3 months
大体时间：Baseline and 3 months
|
Health Scale Euroqol EQ-5D will be used for this outcome
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Baseline and 3 months
|
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Change from Baseline Mood at three months
大体时间：Baseline and 3 months
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An analogic scale will be used for this outcome in wich 0 points is the best mood and 10 points is worst mood
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Baseline and 3 months
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Change from Baseline Cramps at three months
大体时间：Baseline and 3 months
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To assess changes in cramps in patients who had them, a general questionnaire about Cramps will be used to assess mainly the intensity and frequency of crambs.
Regarding the intensity 0 is the lower pain and 10 is the worst pain
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Baseline and 3 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年11月23日
初级完成 (实际的)
2018年3月31日
研究完成 (实际的)
2018年4月15日
研究注册日期
首次提交
2018年1月16日
首先提交符合 QC 标准的
2018年2月9日
首次发布 (实际的)
2018年2月12日
研究记录更新
最后更新发布 (实际的)
2018年5月11日
上次提交的符合 QC 标准的更新
2018年5月10日
最后验证
2018年5月1日
更多信息
与本研究相关的术语
其他研究编号
- QUbiquinol17
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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