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临床试验/NCT05378009
NCT05378009Unknown不适用

Functional Dyspepsia Response to Relaxation Therapy Alone or Combined With Physical Activity

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
cortisol

研究概览

简要总结

Functional dyspepsia (FD) is a common gastrointestinal disease with high morbidity. Due to the drop in estrogen level, perimenopausal women with FD (PMFD) have an increase in emotional disorders such as depression, anxiety and sleep disorder.

详细描述

the research will include 30 FD women during their perimenopause to receive for 8 weeks the following: relaxation therapy (Benson relaxation), physical exercise (on treadmill), and proton pump inhibitors. Also, the research will include another 30 FD women during their perimenopause to receive for 8 weeks the following: relaxation therapy (Benson relaxation) and proton pump inhibitors

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
Single (Outcomes Assessor)

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

  • perimenopausal women With FD symptoms

排除标准

  • other gastrointestinal disease
  • Cardiovascular, metabolic, respiratory, renal complaints
  • Pregnancy
  • Women in Lactation
  • neurological / Psychic Women

结局指标

主要结局

cortisol

时间窗: It will be measured after 8 weeks

stress hormone will be measured in serum

次要结局

  • Estradiol(It will be measured after 8 weeks)
  • depression anxiety stress scales-42(It will be measured after 8 weeks)
  • Pittsburgh sleep quality index(It will be measured after 8 weeks)
  • Glasgow dyspepsia severity score(It will be measured after 8 weeks)
  • Visual analogue scale(It will be measured after 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Mohamed Ali ismail

lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Cairo University

研究点 (1)

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