跳至主要内容
临床试验/NCT04225559
NCT04225559Unknown不适用

Analysis of Gastrointestinal Symptoms of Outpatients With Functional Gastrointestinal Diseases(FGIDs) in Grade-A Tertiary Hospitals in China

Xiyuan Hospital of China Academy of Chinese Medical Sciences16 个研究点 分布在 1 个国家目标入组 4,632 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
4,632
试验地点
16
主要终点
Rome IV functional gastrointestinal disease diagnosis questionnaire

研究概览

简要总结

To analyze the classification characteristics of gastrointestinal symptoms, the quality of life, the degree of anxiety and depression, and the satisfaction with the treatment of Chinese medicine in patients with FGIDs in Chinese Grade-A Tertiary Hospitals.

The characteristics of TCM(Traditional Chinese Medicine) syndromes and symptoms of the above-mentioned FGIDs will be analyzed, and the characteristics of TCM syndromes of FGIDs and their possible relationship with FGIDs subtypes will be analyzed.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Symptoms has appeared for at least 3 months;
  • No organic disease and gastrointestinal alarm symptoms, which meet the diagnostic criteria of FGIDs;
  • Sign informed consent and be able to read and understand the questionnaire.

排除标准

  • A history of organic gastrointestinal diseases;
  • Alarm symptoms of digestive tract (such as melena, weight loss, fever, abdominal mass, ascites, anemia, family history of gastrointestinal tumors, etc.)
  • Have a history of mental diseases;
  • Unable to read and understand the questionnaire.

结局指标

主要结局

Rome IV functional gastrointestinal disease diagnosis questionnaire

时间窗: baseline

Fill in only at the time of the patient's consultation, to assess the patient's current situation.Investigation of patients with functional gastrointestinal symptoms according to Rome IV diagnostic criteria.Determine the type of disease based on the questionnaire.

次要结局

  • PHQ-15 Scale(baseline)
  • SF-36 Scale(baseline)
  • Hospital Anxiety and Depression Scale (HADS)(baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (16)

Loading locations...

相似试验