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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention (observational study with diagnostic assessments only).
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other 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.
Primary outcome measures
- Tongue-coating metabolomic profiles in patients with inflammatory bowel disease compared with healthy controls [Time frame: At enrollment (single visit; cross-sectional assessment)]
Secondary outcome measures (8)
- Constitution in Chinese Medici n e Questionnaire, CCMQ [Time frame: At enrollment (single visit; cross-sectional assessment)]
- Gastrointestinal Symptom Rating Scale , GSRS [Time frame: At enrollment (single visit; cross-sectional assessment)]
- Hospital Anxiety and Depressio n Scale, HADS [Time frame: At enrollment (single visit; cross-sectional assessment)]
- Crohn's Disease Activity Index CDAI [Time frame: At enrollment (single visit; cross-sectional assessment)]
- Partial Mayo Scoring Index, pM ayo [Time frame: At enrollment (single visit; cross-sectional assessment)]
- Tongue diagnostic device [Time frame: At enrollment (single visit; cross-sectional assessment)]
- Listening diagnostic device [Time frame: At enrollment (single visit; cross-sectional assessment)]
- Pulse diagnostic device [Time frame: At enrollment (single visit; cross-sectional assessment)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Taiwan · 1 center
- China Medical University Hospital — Taichung
Identifiers
NCT: NCT07314151 · CMUH113-REC2-014