跳至主要内容
临床试验/NCT04878081
NCT04878081尚未招募不适用

The Relationship Between Day and Night Hot Flash During Menopause and Different Traditional Chinese Constitution Types in Women

China Medical University Hospital1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
63
试验地点
1
主要终点
the change of daily hot flush symptoms

研究概览

简要总结

We use Hot Flash Diaries to record the change of daily hot flush symptoms, The Hot Flash Related Daily Interference Scale to record how much did hot flush effect daily life, the Kupperman menopausal index to evaluate the severity of menopausal symptoms, the Pittsburgh Sleep Quality Index to evaluate sleep disorder, wireless temperature monitor to record hot flush and body temperature during sleeping, and classify patients' traditional Chinese constitution by using Physical classification and judgment self-test table. With these evaluations, we can take apart of different syndromes with different symptom of menopause, thus to confirm the specificity and the severity of menopausal hot flush, and give patients correct treatment.

详细描述

Menopause syndrome or Climacteric syndrome is defined as decreasing function of ovarian follicles during menopause. This situation leads to the decreased concentration of estrogen, and causes a series of physical and psychological symptoms, with main symptoms of hot flush, night sweats, dizziness or headache, limbs soreness, insomnia, anxiety and depression. Approximately 40-60 % of menopausal women have the problem of menopausal symptoms, these symptoms severely affect the life quality of post-menopausal women. We use Hot Flash Diaries to record the change of daily hot flush symptoms, The Hot Flash Related Daily Interference Scale to record how much did hot flush effect daily life, the Kupperman menopausal index to evaluate the severity of menopausal symptoms, the Pittsburgh Sleep Quality Index to evaluate sleep disorder, wireless temperature monitor to record hot flush and body temperature during sleeping, and classify patients' traditional Chinese constitution by using Physical classification and judgment self-test table. With these evaluations, we can take apart of different syndromes with different symptom of menopause, thus to confirm the specificity and the severity of menopausal hot flush, and give patients correct treatment.

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
40 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • not accept Chinese medicine therapy for last 3 months
  • 40-55 years old female
  • prolonged menstruation with hot flush, night sweats or insomnia
  • regular night sleep habit
  • not take oral contraceptive pill for last 6 months
  • no smoking, alcohol, drug abused

排除标准

  • any types of Systemic disease
  • any chronic disease under medicine control
  • any mental disorder
  • pregnant women

结局指标

主要结局

the change of daily hot flush symptoms

时间窗: 30 days

the change of daily hot flush symptoms

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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