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Analysis of Gastrointestinal Symptoms of Outpatients With Functional Gastrointestinal Diseases(FGIDs) in Grade-A Tertiary Hospitals in China

Analysis of Gastrointestinal Symptoms of Outpatients With Functional Gastrointestinal Diseases(FGIDs) in Grade-A Tertiary Hospitals in China

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04225559
Enrollment
4632
Registered
2020-01-13
Start date
2019-11-01
Completion date
2021-12-31
Last updated
2020-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To Analyze TCM Syndrome and Symptoms of FGIDs Patients

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.

Interventions

None listed

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Rome IV functional gastrointestinal disease diagnosis questionnairebaselineFill 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

MeasureTime frameDescription
PHQ-15 ScalebaselineFill 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 ScalebaselineFill 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)baselineFill 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).

Countries

China

Contacts

Primary ContactFengyun Wang, Medical Doctor
wfy811@163.com86-010-62835610

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026