NCT04202588

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,632

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 24, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

November 25, 2019

Last Update Submit

January 21, 2022

Conditions

Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (2)

  • Distribution of different subtypes with Functional gastrointestinal disorders (FGIDs) in China

    The percentage of the different subtypes with FGIDs by Rome IV Diagnostic Criteria

    2 years

  • The health-related quality of life (HRQOL) of outpatients with FGIDs in China

    The HRQOL scale contains 36 questions scoring from 0 to 4. Higher score means a worse outcome. The highest total score is 144.

    2 years

Secondary Outcomes (5)

  • Demographic characteristics of outpatients with FGIDs in China

    2 years

  • Quality of life of outpatients with FGIDs in China

    2 years

  • HAMA scoring of outpatients with FGIDs in China

    2 years

  • HAMD scoring of outpatients with FGIDs in China

    2 years

  • Treatment satisfaction score of CM interventions in outpatients with FGIDs in China

    2 years

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatients of third-class hospitals across China

You may qualify if:

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

You may not qualify if:

  • Combined with organic gastrointestinal diseases
  • Appearance of gastrointestinal alarm symptoms
  • Combined with mental disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linda Zhong

Kowloon Tong, Kowloon, Hong Kong

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Central Study Contacts

Sonia Low, BNurse

CONTACT

852-34116523soniagoh@hkbu.edu.hk

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 25, 2019

First Posted

December 17, 2019

Study Start

January 1, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

January 24, 2022

Record last verified: 2022-01

Locations

HK(1)