To Analyze TCM Syndrome and Symptoms of FGIDs Patients Clinical Trial
Official title:
Analysis of Gastrointestinal Symptoms of Outpatients With Functional Gastrointestinal Diseases（FGIDs） in Grade-A Tertiary Hospitals in China
| NCT number | NCT04225559 |
| Other study ID # | XL018 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 1, 2019 |
| Est. completion date | December 31, 2021 |
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.
| Status | Recruiting |
| Enrollment | 4632 |
| Est. completion date | December 31, 2021 |
| Est. primary completion date | November 4, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Xiyuan hospital | Beijing | Beijing |
| China | Beijing Hospital of Traditional Chinese Medicine, Capital Medical University | Dongcheng | 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 | Hong Kong Chinese Medicine Clinical Study Centre | Hong Kong | |
| China | School of Chinese Medicine,Hong Kong Baptist University | Hong Kong | |
| China | Liuzhou Traditional Chinese Medical Hospital | Liuzhou | Guangxi |
| China | Jiangsu Provincial Hospital of Chinese Medicine | Nanjing | Jiangsu |
| China | Institute of Digestive Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine | Shanghai | Shanghai |
| China | The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, | Shenyang | Liaoning |
| China | Shanxi Provincial Hospital Of Traditional Chinese Medicine | Taiyuan | Shanxi |
| China | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine | Tianjin | Tianjin |
| China | Wuhan Hospital Of Traditional Chinese And Western Medicine(WUHAN No.1 HOSPITAL) | Wuhan | Hubei |
| China | The Affiliated Hospital of Shaanxi, University of Chinese Medicine, | Xianyang | Shaanxi |
| China | Guang'anmen Hospital,China Academy of Chinese Medical Science | Xicheng | Beijing |
| China | The First Affiliated Hospital of Henan University of Chinese Medicine | Zhengzhou | Henan |
| Lead Sponsor | Collaborator |
|---|---|
| Xiyuan Hospital of China Academy of Chinese Medical Sciences |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rome IV functional gastrointestinal disease diagnosis questionnaire | 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. | baseline | |
| Secondary | PHQ-15 Scale | 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. | baseline | |
| Secondary | SF-36 Scale | 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. | baseline | |
| Secondary | Hospital Anxiety and Depression Scale (HADS) | 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). | baseline |