Study on the Use of Traditional Chinese Medicine Diagnostic Tools to Assist in Identifying the Clinical Characteristics of Inflammatory Bowel Disease and Research on Metabolic Plastids of Tongue Coating

NCT ID: NCT07314151

Last Updated: 2026-01-02

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

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-15

Study Completion Date

2026-07-31

Brief Summary

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This study will be conducted at the outpatient clinic of China Medical University hospital. It is expected to enroll two groups of 30 subjects, including the experimental group must meet the clinical diagnosis of IBD, and the control group without IBD and have no obvious gastrointestinal symptoms . This proje ct uses modern TCM diagnostic tools, such as tongue diagnosis instrument, auscul tation instrument, TCM constitution questionnaire, and pulse diagnosis instrument to establish the comparison of physiological and biochemical indicators such as TCM phenotype and laboratory tests data in patients with IBD. Besides, another purpose of this project is to analyze the tongue coating metabolites of patients with IBD by mass spectrometry, and to establish a research model of tongue coating an d metabolomics for patien ts with IBD and the prognosis analysis of acute and remission phases.

Detailed Description

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Conditions

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Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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IBD Patient Cohort

No intervention (observational study with diagnostic assessments only)

Intervention Type OTHER

This observational study involves no therapeutic or behavioral intervention. Participants undergo non-invasive assessments including Traditional Chinese Medicine four-diagnostic measurements (inspection, listening/smelling, inquiry, and pulse assessment), completion of standardized questionnaires, and collection of tongue-coating samples for metabolomic analysis.

Healthy Control Cohort

No intervention (observational study with diagnostic assessments only)

Intervention Type OTHER

This observational study involves no therapeutic or behavioral intervention. Participants undergo non-invasive assessments including Traditional Chinese Medicine four-diagnostic measurements (inspection, listening/smelling, inquiry, and pulse assessment), completion of standardized questionnaires, and collection of tongue-coating samples for metabolomic analysis.

Interventions

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No intervention (observational study with diagnostic assessments only)

This observational study involves no therapeutic or behavioral intervention. Participants undergo non-invasive assessments including Traditional Chinese Medicine four-diagnostic measurements (inspection, listening/smelling, inquiry, and pulse assessment), completion of standardized questionnaires, and collection of tongue-coating samples for metabolomic analysis.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients aged 18 years or older who are able to provide informed consent and comply with the study procedures.
* Experimental group: Patients with a primary diagnosis of Crohn's disease or ulcerative colitis, defined by ICD-10-CM codes K50-K51.
* Control group: Individuals without inflammatory bowel disease and without significant gastrointestinal symptoms.

Exclusion Criteria

* Individuals who are unable to provide informed consent or unable to comply with study procedures or questionnaires.
* Individuals who have undergone major surgery or received chemotherapy or radiotherapy within the past month.
* Pregnant women.
* Individuals deemed unsuitable for participation in this study by the attending physician.
* Control group exclusions:

* Individuals with any diagnosed psychiatric disorder.
* Individuals with any major gastrointestinal disease, such as gastrointestinal malignancy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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China Medical University Hospital

Taichung, North, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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Hou

Role: primary

+886937313675

Other Identifiers

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CMUH113-REC2-014

Identifier Type: -

Identifier Source: org_study_id

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