Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)NCT07314151
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
An observational study of Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Feb 2024to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will be conducted in the outpatient clinics of China Medical University Hospital and is designed to enroll two groups of participants, with 100 individuals aged 18 years or older in each group. The experimental group will include patients who meet the clinical diagnostic criteria for inflammatory bowel disease (IBD), while the control group will consist of individuals without IBD and without significant gastrointestinal symptoms. All participants will receive a detailed explanation of the study from research personnel. Those who agree to participate and pass the initial screening will be required to sign an informed consent form for human clinical research and subsequently undergo the relevant assessments and procedures.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, North, 404
Hou, +886937313675, d38316cmuh@gmail.com
About this study
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.
- Being tested
- No intervention (observational study with diagnostic assessments only)
- Keywords
- inflammatory bowel disease, Crohn's disease, ulcerative colitis, gut brain axis, Traditional Chinese medicine (TCM) diagnosis, Tongue diagnosis, Metabolomics
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study with diagnostic assessments only)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.
| Study group | Role | What they receive |
|---|---|---|
| IBD Patient Cohort | Not described Receives: Other: No intervention (observational study with diagnostic assessments only) | |
| Healthy Control Cohort | Not described Receives: Other: No intervention (observational study with diagnostic assessments only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tongue-coating metabolomic profiles in patients with inflammatory bowel disease compared with healthy controls
After tongue-coating collection, the samples (approximately 20-50 mg) are weighed and stored at -80 °C until all samples have been collected. Metabolite extraction is then performed, followed by analysis of metabolite signals using liquid chromatography-mass spectrometry. The primary analytical platform consists of an ACQUITY UPLC I-Class System (Waters) coupled with a Vion IMS Q-ToF mass spectrometer (Waters).
The acquired chromatographic and mass spectrometric data are further processed using the omics analysis software Progenesis QI to identify intergroup differences. Metabolite signal differences between the acute and remission phases are evaluated using principal component analysis (PCA) and partial least squares discriminant analysis (PLS-DA). Subsequently, differential metabolite signals are matched against reference databases for metabolite identification. Upon completion of metabolite identification and data acquisition, disease phase-specific metabolomic signature patterns
Measured: At enrollment (single visit; cross-sectional assessment)
Secondary outcomes (8)
Constitution in Chinese Medici n e Questionnaire, CCMQ
During participant enrollment, questionnaires are administered by research personnel. Participants are instructed to complete the questionnaires independently based on their subjective perceptions, with efforts made to minimize external interference that may influence their responses. Questionnaire results are scored and categorized according to the established scoring criteria.
Measured: At enrollment (single visit; cross-sectional assessment)
Gastrointestinal Symptom Rating Scale , GSRS
The Gastrointestinal Symptom Rating Scale (GSRS) assesses 15 common gastrointestinal symptoms grouped into five symptom domains: abdominal pain, diarrhea, gastroesophageal reflux, indigestion, and constipation. Each item is rated on a 7-point Likert scale ranging from "no discomfort" to "very severe discomfort," with participants self-assessing the severity of their gastrointestinal symptoms over the preceding week. Higher scores indicate greater symptom severity.
The GSRS provides a brief yet comprehensive assessment of common gastrointestinal symptoms and demonstrates good internal consistency and psychometric validity. The reported Cronbach's alpha values range from 0.74 to 0.85, and the test-retest reliability ranges from 0.55 to 0.70.
Measured: At enrollment (single visit; cross-sectional assessment)
Hospital Anxiety and Depressio n Scale, HADS
The Hospital Anxiety and Depression Scale (HADS) consists of 14 items, with 7 items assessing anxiety (HADS-A) and 7 items assessing depression (HADS-D), each scored separately. Items are rated on a 4-point scale ranging from 0 to 3, with higher scores indicating greater severity of anxiety or depression. According to the original authors' recommendations, scores of 7 or below indicate no anxiety or depression, scores of 8-10 suggest possible anxiety or depression, and scores of 11 or higher indicate a high likelihood of clinically significant anxiety or depression.
Measured: At enrollment (single visit; cross-sectional assessment)
Crohn's Disease Activity Index CDAI
The assessment consists of eight clinical variables, including subjective symptoms over the preceding week (such as abdominal pain severity and overall well-being), objective measures (such as the use of antidiarrheal medications and percentage change in body weight), and laboratory parameters. After individual component scores are recorded, a weighted calculation is applied to generate the total score. Higher scores indicate greater disease activity, with a CDAI score of less than 150 indicating disease remission and a score greater than 450 indicating extremely severe disease activity.
Measured: At enrollment (single visit; cross-sectional assessment)
Partial Mayo Scoring Index, pM ayo
The partial Mayo (pMayo) scoring index primarily records stool frequency, rectal bleeding, and physician's global assessment in patients with ulcerative colitis. Each component is scored on a scale of 0 to 3, yielding a total score ranging from 0 to 9, with higher scores indicating greater disease activity. The pMayo score demonstrates a specificity of 0.84 for identifying disease remission and a sensitivity of 0.71.
Measured: At enrollment (single visit; cross-sectional assessment)
Tongue diagnostic device
Tongue images are captured from a frontal view with the participant's head stabilized on the tongue diagnostic examination platform. Each participant is instructed to protrude the tongue naturally during image acquisition. After image capture, the images are transmitted to a computer for processing. The photographs are first calibrated using a standard color reference card to correct pixel color deviations, and tongue features are subsequently analyzed using a computer-assisted interpretation system to support Traditional Chinese Medicine tongue diagnosis. The assessed tongue features include:
- Tongue shape: small, medium, or enlarged.
- Tongue color: pale, light red, red, or purplish.
- Tongue body features: red dots, petechiae/ecchymosis, teeth marks, and fissures.
- Coating color: white or yellow.
- Coating thickness: scant, thin, or thick.
- Saliva (moisture): scant, normal, or excessive.
- Sublingual collateral veins: normal or abnormal.
Measured: At enrollment (single visit; cross-sectional assessment)
Listening diagnostic device
The listening diagnostic device is based on a computerized acoustic analysis system that provides functions for voice signal analysis and management of participants' voice data. The core technology involves recording a one-second sustained vowel sound (e.g., /a/) to quantify acoustic parameters and perform model-based analyses. Medical research and published studies have demonstrated that the derived parameters are capable of distinguishing deficiency-related constitutional characteristics among different participants, making this system a practical diagnostic tool for rapid constitutional assessment during Traditional Chinese Medicine clinical syndrome differentiation.
Measured: At enrollment (single visit; cross-sectional assessment)
Pulse diagnostic device
Clinical pulse signals are analyzed using time-domain methods to evaluate pulse position, rate, rhythm, and waveform characteristics The system automatically interprets Traditional Chinese Medicine syndrome patterns to assist physicians in clinical diagnosis and syndrome differentiation.
Using the pulse diagnostic device, objective and quantifiable parameters can be obtained, including pulse waveform data, blood pressure (systolic/diastolic), heart rate (beats per minute), cardiac arrhythmia indices (number of irregular heartbeats within a five-minute period), heart rate variability (HRV; overall autonomic nervous system activity), low-frequency power (LF; sympathetic nervous system activity), high-frequency power (HF; parasympathetic nervous system activity), and the LF/HF ratio, which reflects the balance between sympathetic and parasympathetic nervous system activity.
Measured: At enrollment (single visit; cross-sectional assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start15 Feb 2024
- Primary completion19 Jan 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)Studies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314151
- Sponsor's protocol ID
- CMUH113-REC2-014
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07314151
- Acronym / sponsor ID
- CMUH113-REC2-014
- Keywords
- inflammatory bowel disease, Crohn's disease, ulcerative colitis, gut brain axis, Traditional Chinese medicine (TCM) diagnosis, Tongue diagnosis, Metabolomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 19 Jan 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD Patient Cohort | – | Other: No intervention (observational study with diagnostic assessments only) |
| Healthy Control Cohort | – | Other: No intervention (observational study with diagnostic assessments only) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted in the outpatient clinics of China Medical University Hospital and is designed to enroll two groups of participants, with 100 individuals aged 18 years or older in each group. The experimental group will include patients who meet the clinical diagnostic criteria for inflammatory bowel disease (IBD), while the control group will consist of individuals without IBD and without significant gastrointestinal symptoms. All participants will receive a detailed explanation of the study from research personnel. Those who agree to participate and pass the initial screening will be required to sign an informed consent form for human clinical research and subsequently undergo the relevant assessments and procedures.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Healthy Control Cohort, IBD Patient Cohort |
Primary outcome
Tongue-coating metabolomic profiles in patients with inflammatory bowel disease compared with healthy controls
Time frame: At enrollment (single visit; cross-sectional assessment)
After tongue-coating collection, the samples (approximately 20-50 mg) are weighed and stored at -80 °C until all samples have been collected. Metabolite extraction is then performed, followed by analysis of metabolite signals using liquid chromatography-mass spectrometry. The primary analytical platform consists of an ACQUITY UPLC I-Class System (Waters) coupled with a Vion IMS Q-ToF mass spectrometer (Waters). The acquired chromatographic and mass spectrometric data are further processed using the omics analysis software Progenesis QI to identify intergroup differences. Metabolite signal differences between the acute and remission phases are evaluated using principal component analysis (PCA) and partial least squares discriminant analysis (PLS-DA). Subsequently, differential metabolite signals are matched against reference databases for metabolite identification. Upon completion of metabolite identification and data acquisition, disease phase-specific metabolomic signature patterns
8 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tongue-coating metabolomic profiles in patients with inflammatory bowel disease compared with healthy controls (time frame: At enrollment (single visit; cross-sectional assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.