A Cross-sectional Investigation on Characteristics of Gastrointestinal Symptoms in China
- Conditions
- Functional Gastrointestinal Disorders
- Registration Number
- NCT04202588
- Lead Sponsor
- Hong Kong Baptist University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 4632
- Symptoms onset at least 3 months
- Meet the diagnostic criteria of FGIDs
- Informed consent and ability to read and understand questionnaires
- Combined with organic gastrointestinal diseases
- Appearance of gastrointestinal alarm symptoms
- Combined with mental disorders
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Distribution of different subtypes with Functional gastrointestinal disorders (FGIDs) in China 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 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.
- Secondary Outcome Measures
Name Time Method Treatment satisfaction score of CM interventions in outpatients with FGIDs in China 2 years Treatment satisfaction will be evaluated using a single question scoring from 0 to 4. A higher score means worse satisfaction.
HAMD scoring of outpatients with FGIDs in China 2 years Hamilton Depression Scale (HAMD) contained and 17 questions scoring form 0 to 4. A high score means a worse depression state.
Demographic characteristics of outpatients with FGIDs in China 2 years Including age, gender, education level, marital status and job categories
Quality of life of outpatients with FGIDs in China 2 years 36-Item Short Form Survey (SF-36) will be used. Thirty items are contained and each item is scored on a 0 to 100 range. A high score defines a more favorable health state.
HAMA scoring of outpatients with FGIDs in China 2 years Hamilton Anxiety Scale (HAMA) contained and 14 questions scoring form 0 to 4. A high score means a worse anxiety state.
Trial Locations
- Locations (1)
Linda Zhong
🇭🇰Kowloon Tong, Kowloon, Hong Kong