Clinical trial NCT04225559: Analysis of Gastrointestinal Symptoms of Outpatients With Functional Gastrointestinal Diseases（FGIDs） in Grade-A Tertiary Hospitals in China
Official title: Analysis of Gastrointestinal Symptoms of Outpatients With Functional Gastrointestinal Diseases（FGIDs） in Grade-A Tertiary Hospitals in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: To Analyze TCM Syndrome and Symptoms of FGIDs Patients
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 4632
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatients in Chinese Grade-A tertiary hospitals who has been diagnosed FGIDs

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Rome IV functional gastrointestinal disease diagnosis questionnaire
timeFrame: baseline
Secondary outcomes:
measure: PHQ-15 Scale
timeFrame: baseline
measure: SF-36 Scale
timeFrame: baseline
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiyuan hospital
state: Beijing
city: Dongcheng
country: China
facility: Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
state: Beijing
city: Xicheng
country: China
facility: Guang'anmen Hospital,China Academy of Chinese Medical Science
state: Beijing
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou Traditional Chinese Medical Hospital
state: Guangxi
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of Chinese Medicine
state: Henan
city: Wuhan
country: China
facility: Wuhan Hospital Of Traditional Chinese And Western Medicine(WUHAN No.1 HOSPITAL)
state: Hubei
city: Hohhot
country: China
facility: Inner Mongolia Autonomous Region Hospital Chinese Medicne
state: Inner Mongolia
city: Nanjing
country: China
facility: Jiangsu Provincial Hospital of Chinese Medicine
state: Jiangsu
city: Shenyang
country: China
facility: The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,
state: Liaoning
city: Xianyang
country: China
facility: The Affiliated Hospital of Shaanxi, University of Chinese Medicine,
state: Shaanxi
city: Shanghai
country: China
facility: Institute of Digestive Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Provincial Hospital Of Traditional Chinese Medicine
state: Shanxi
city: Tianjin
country: China
facility: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
state: Tianjin
city: Hong Kong
country: China
facility: Hong Kong Chinese Medicine Clinical Study Centre
city: Hong Kong
country: China
facility: School of Chinese Medicine,Hong Kong Baptist University
Study officials:
References: