Analysis of Gastrointestinal Symptoms of Outpatients With Functional Gastrointestinal Diseases（FGIDs） in Grade-A Tertiary Hospitals in China
- Conditions
- To Analyze TCM Syndrome and Symptoms of FGIDs Patients
- Registration Number
- NCT04225559
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 4632
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rome IV functional gastrointestinal disease diagnosis questionnaire 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.
- Secondary Outcome Measures
Name Time Method PHQ-15 Scale baseline Fill in only at the time of the patient's consultation, to assess the patient's current situation.Score evaluation from of physical symptoms in patients with functional gastrointestinal disorders from 15 aspects. 0-4 points: very mild， 5-9 points: mild ，10-14 points: moderate，15-30 points: severe.
SF-36 Scale baseline Fill in only at the time of the patient's consultation, to assess the patient's current situation.Score evaluation from 8 aspects: physical function, role-physical, pain, global health status, vitality，social function,role-emotional， mental health.Use score changes to assess improvement in all areas of the patient. Maximum score is147.The higher the score, the better the status in all aspects.
Hospital Anxiety and Depression Scale (HADS) baseline Fill in only at the time of the patient's consultation, to assess the patient's current situation.Scoring to determine if a patient has symptoms of anxiety and depression：(0-7: asymptomatic， 8-10: suspicious symptoms， 11-21: there must be symptoms).
Trial Locations
- Locations (16)
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
🇨🇳Dongcheng, Beijing, China
The First Affiliated Hospital of Henan University of Chinese Medicine
🇨🇳Zhengzhou, Henan, China
Wuhan Hospital Of Traditional Chinese And Western Medicine(WUHAN No.1 HOSPITAL)
🇨🇳Wuhan, Hubei, China
Liuzhou Traditional Chinese Medical Hospital
🇨🇳Liuzhou, Guangxi, China
Jiangsu Provincial Hospital of Chinese Medicine
🇨🇳Nanjing, Jiangsu, China
Hong Kong Chinese Medicine Clinical Study Centre
🇨🇳Hong Kong, China
Xiyuan hospital
🇨🇳Beijing, Beijing, China
Guang'anmen Hospital,China Academy of Chinese Medical Science
🇨🇳Xicheng, Beijing, China
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
🇨🇳Guangzhou, Guangdong, China
Inner Mongolia Autonomous Region Hospital Chinese Medicne
🇨🇳Hohhot, Inner Mongolia, China
The Affiliated Hospital of Shaanxi, University of Chinese Medicine,
🇨🇳Xianyang, Shaanxi, China
The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,
🇨🇳Shenyang, Liaoning, China
Institute of Digestive Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China
Shanxi Provincial Hospital Of Traditional Chinese Medicine
🇨🇳Taiyuan, Shanxi, China
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
🇨🇳Tianjin, Tianjin, China
School of Chinese Medicine,Hong Kong Baptist University
🇨🇳Hong Kong, China