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A Cross-sectional Investigation on Characteristics of Gastrointestinal Symptoms in China

NCT ID: NCT04202588

Last Updated: 2022-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

4632 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-01-31

Brief Summary

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The investigators will conduct a multicenter cross-sectional study to discover symptom characteristics, quality of life, severity of anxiety and depression, status of lactose intolerance and treatment satisfaction of current Chinese Medicine (CM) regimens of outpatients with FGIDs. In the meanwhile, the investigators will also analyze the characters of CM patterns and corresponding elements, then explore the potential relationship between CM patterns and FGIDs' subtypes.

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Detailed Description

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This is a multicenter cross-sectional study to discover symptom characteristics, quality of life, severity of anxiety and depression, status of lactose intolerance and treatment satisfaction of current Chinese Medicine (CM) regimens of outpatients with FGIDs. Afterwards, the investigators will explore the potential relationship between CM patterns and FGIDs' subtypes based on collected information. It is estimated that 4,632 outpatients from 18 centers across China will be recruited. Various demographic and disease-related information will be documented, including name, gender, age, education level, marital status, job category, disease course, medical consultation experience, current CM regimens and rationale, and treatment satisfaction. Patients will also complete a series of scales, containing, Rome IV Diagnostic Questionnaire, Patient-Reported Outcome (PRO) scale, the 36-Item Short Form Survey (SF-36), Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD), lactose food frequency questionnaire (Lactose FFQ) and CM pattern scale. The primary outcome will be the symptom characteristics of outpatients with FGIDs. Secondary outcomes include population characteristics of FGID patients (quality of life, emotional status, lactose intolerance status, and satisfaction level of CM interventions), and potential association between CM patterns and FGIDs' subtypes.

Conditions

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Functional Gastrointestinal Disorders

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Symptoms onset at least 3 months
* Meet the diagnostic criteria of FGIDs
* Informed consent and ability to read and understand questionnaires

Exclusion Criteria

* Combined with organic gastrointestinal diseases
* Appearance of gastrointestinal alarm symptoms
* Combined with mental disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role collaborator

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Jiangsu Province Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Higher Education Mega Center Branch of Guangdong Provincial Hospital of Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Wuhan Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Hospital of Shanxi University of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

The First Affiliated Hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role collaborator

Liuzhou Traditional Chinese Medical Hospital

UNKNOWN

Sponsor Role collaborator

Shaanxi Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role collaborator

Beijing Hospital of Traditional Chinese Medicine Affiliated with Capital Medical University

UNKNOWN

Sponsor Role collaborator

Henan University of Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Second Affiliated Hospital of Fujian Traditional Chinese Medical University

UNKNOWN

Sponsor Role collaborator

Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Hong Kong Baptist University

OTHER

Sponsor Role lead

Responsible Party

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Zhong Lidan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Linda Zhong

Kowloon Tong, Kowloon, Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Sonia Low, BNurse

Role: CONTACT

[email protected]
852-34116523

Facility Contacts

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Linda Zhong, MD,PhD

Role: primary

[email protected]
34116523

Other Identifiers

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NationCor-FGID

Identifier Type: -

Identifier Source: org_study_id

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