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临床试验/NCT04202588
NCT04202588Unknown不适用

Gastrointestinal Symptoms Characteristics and Chinese Medicine Patterns in Patients With Functional Gastrointestinal Disorders (FGIDs) in China: a Multicenter Cross-sectional Investigation

Hong Kong Baptist University1 个研究点 分布在 1 个国家目标入组 4,632 人开始时间: 2020年1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
1
主要终点
Distribution of different subtypes with Functional gastrointestinal disorders (FGIDs) in China

研究概览

简要总结

The investigators will conduct a multicenter cross-sectional study to discover symptom characteristics, quality of life, severity of anxiety and depression, status of lactose intolerance and treatment satisfaction of current Chinese Medicine (CM) regimens of outpatients with FGIDs. In the meanwhile, the investigators will also analyze the characters of CM patterns and corresponding elements, then explore the potential relationship between CM patterns and FGIDs' subtypes.

详细描述

This is a multicenter cross-sectional study to discover symptom characteristics, quality of life, severity of anxiety and depression, status of lactose intolerance and treatment satisfaction of current Chinese Medicine (CM) regimens of outpatients with FGIDs. Afterwards, the investigators will explore the potential relationship between CM patterns and FGIDs' subtypes based on collected information. It is estimated that 4,632 outpatients from 18 centers across China will be recruited. Various demographic and disease-related information will be documented, including name, gender, age, education level, marital status, job category, disease course, medical consultation experience, current CM regimens and rationale, and treatment satisfaction. Patients will also complete a series of scales, containing, Rome IV Diagnostic Questionnaire, Patient-Reported Outcome (PRO) scale, the 36-Item Short Form Survey (SF-36), Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD), lactose food frequency questionnaire (Lactose FFQ) and CM pattern scale. The primary outcome will be the symptom characteristics of outpatients with FGIDs. Secondary outcomes include population characteristics of FGID patients (quality of life, emotional status, lactose intolerance status, and satisfaction level of CM interventions), and potential association between CM patterns and FGIDs' subtypes.

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 onset at least 3 months
  • Meet the diagnostic criteria of FGIDs
  • Informed consent and ability to read and understand questionnaires

排除标准

  • Combined with organic gastrointestinal diseases
  • Appearance of gastrointestinal alarm symptoms
  • Combined with mental disorders

结局指标

主要结局

Distribution of different subtypes with Functional gastrointestinal disorders (FGIDs) in China

时间窗: 2 years

The percentage of the different subtypes with FGIDs by Rome IV Diagnostic Criteria

The health-related quality of life (HRQOL) of outpatients with FGIDs in China

时间窗: 2 years

The HRQOL scale contains 36 questions scoring from 0 to 4. Higher score means a worse outcome. The highest total score is 144.

次要结局

  • Treatment satisfaction score of CM interventions in outpatients with FGIDs in China(2 years)
  • HAMD scoring of outpatients with FGIDs in China(2 years)
  • HAMA scoring of outpatients with FGIDs in China(2 years)
  • Demographic characteristics of outpatients with FGIDs in China(2 years)
  • Quality of life of outpatients with FGIDs in China(2 years)

研究者

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

Zhong Lidan

Assistant Professor

Hong Kong Baptist University

研究点 (1)

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