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Идёт набор 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

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: No intervention (observational study with diagnostic assessments only).
Кому может быть актуально
Состояния в реестре: Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

  • Другое 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.

Первичные конечные точки

  • Tongue-coating metabolomic profiles in patients with inflammatory bowel disease compared with healthy controls [Срок оценки: At enrollment (single visit; cross-sectional assessment)]
Вторичные конечные точки (8)
  • Constitution in Chinese Medici n e Questionnaire, CCMQ [Срок оценки: At enrollment (single visit; cross-sectional assessment)]
  • Gastrointestinal Symptom Rating Scale , GSRS [Срок оценки: At enrollment (single visit; cross-sectional assessment)]
  • Hospital Anxiety and Depressio n Scale, HADS [Срок оценки: At enrollment (single visit; cross-sectional assessment)]
  • Crohn's Disease Activity Index CDAI [Срок оценки: At enrollment (single visit; cross-sectional assessment)]
  • Partial Mayo Scoring Index, pM ayo [Срок оценки: At enrollment (single visit; cross-sectional assessment)]
  • Tongue diagnostic device [Срок оценки: At enrollment (single visit; cross-sectional assessment)]
  • Listening diagnostic device [Срок оценки: At enrollment (single visit; cross-sectional assessment)]
  • Pulse diagnostic device [Срок оценки: At enrollment (single visit; cross-sectional assessment)]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Тайвань · 1 центр
  • China Medical University Hospital — Taichung

Идентификаторы

NCT: NCT07314151 · CMUH113-REC2-014

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗