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

April 30, 2020 updated by: Xiyuan Hospital of China Academy of Chinese Medical Sciences

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

4632

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Recruiting
        • Hong Kong Chinese Medicine Clinical Study Centre
        • Contact:
          • Lidan Zhong
      • Hong Kong, China
        • Recruiting
        • School of Chinese Medicine,Hong Kong Baptist University
        • Contact:
          • Lidan Zhong
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • Xiyuan Hospital
        • Contact:
          • Fengyun Wang, MD
          • Phone Number: 010-86-62835610
          • Email: wfy811@163.com
      • Dongcheng, Beijing, China, 100010
        • Recruiting
        • Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
        • Contact:
          • Hongbing Wang
      • Xicheng, Beijing, China, 100053
        • Recruiting
        • Guang'anmen Hospital,China Academy of Chinese Medical Science
        • Contact:
          • Bin Zhou
    • Guangdong
      • Guangzhou, Guangdong, China, 510006
        • Recruiting
        • The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
        • Contact:
          • Shaogang Huang
    • Guangxi
      • Liuzhou, Guangxi, China
        • Recruiting
        • Liuzhou Traditional Chinese Medical Hospital
        • Contact:
          • Xiaoling Zhou
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • the First Affiliated Hospital of Henan University of Chinese Medicine
        • Contact:
          • Suping Ma
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Wuhan Hospital Of Traditional Chinese And Western Medicine(WUHAN No.1 HOSPITAL)
        • Contact:
          • Jiayao Yang
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China
        • Recruiting
        • Inner Mongolia Autonomous Region Hospital Chinese Medicne
        • Contact:
          • yuxia wei
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Provincial Hospital of Chinese Medicine
        • Contact:
          • Bai Ye
    • Liaoning
      • Shenyang, Liaoning, China
        • Recruiting
        • The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,
        • Contact:
          • Guang Bai
    • Shaanxi
      • Xianyang, Shaanxi, China, 712000
        • Recruiting
        • The Affiliated Hospital of Shaanxi, University of Chinese Medicine,
        • Contact:
          • Jiehong Wang
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Institute of Digestive Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine
        • Contact:
          • Jianye Yuan
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • Shanxi Provincial Hospital of Traditional Chinese Medicine
        • Contact:
          • Juanping Su
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
        • Contact:
          • Zhenghua Zhou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Outpatients in Chinese Grade-A tertiary hospitals who has been diagnosed FGIDs

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rome IV functional gastrointestinal disease diagnosis questionnaire
Time Frame: 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.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PHQ-15 Scale
Time Frame: 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.
baseline
SF-36 Scale
Time Frame: 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.
baseline
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 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).
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

November 4, 2019

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

December 29, 2019

First Submitted That Met QC Criteria

January 8, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

May 1, 2020

Last Update Submitted That Met QC Criteria

April 30, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XL018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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