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

China Medical University

Status: Enrolling

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

Treatments: Other: No intervention (observational study with diagnostic assessments only)

Study type: Observational

Funder types: Other

Identifiers

NCT07314151

CMUH113-REC2-014

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

IBD Patient Cohort

Treatment:

Other: No intervention (observational study with diagnostic assessments only)

Healthy Control Cohort

Treatment:

Other: No intervention (observational study with diagnostic assessments only)