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Идёт набор NCT04187820

Effect of Acupuncture on Mild to Moderate Active Crohn's Disease

Без фазы С лечением Intestinal Disorder Inflammatory Bowel Diseases Crohn Disease

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: acupuncture.
Кому может быть актуально
Состояния в реестре: Intestinal Disorder, Inflammatory Bowel Diseases, Crohn Disease. Базовые параметры: 16 лет — 70 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effect of Acupuncture on Crohn's Disease Via the Regulation of Trp-kyn Metabolism in Brain-gut Axis

Обзор

To observe the clinical effect of acupuncture on Crohn's disease (CD) and its influence on brain function activity and the TRY-KYN metabolism level, and to screen the brain image markers of acupuncture on CD

Подробное описание

1. Effect of acupuncture on symptoms of CD 2. Effect of acupuncture on brain functional activity of CD 3. Effect of acupuncture on intestinal and plasma TRP-KYN metabolism level of CD 4. Screen the brain image markers of acupuncture in the treatment of CD

Вмешательства

  • Другое acupuncture
    Patients receiving acupuncture and mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and ST36 were selected for moxibustion. In the acupuncture group, Hwato acupuncture device was used to blind the subjects, and had the deqi sensation. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustIon.

Первичные конечные точки

  • Clinical remission [Срок оценки: Week 12]
Вторичные конечные точки (12)
  • Clinical remission [Срок оценки: Week 24, 36 and 48]
  • Clinical response [Срок оценки: Week 12, 24, 36 and 48]
  • Crohn's disease activity index （CDAI）score [Срок оценки: Week 12, 24, 36 and 48]
  • laboratory test [Срок оценки: Week 12, 24, 36 and 48]
  • laboratory test [Срок оценки: Week 12, 24, 36 and 48]
  • laboratory test [Срок оценки: Week 12, 24, 36 and 48]
  • Inflammatory bowel disease questionnaire (IBDQ) [Срок оценки: Week 12 and 24]
  • Crohn's disease endoscopic index of severity (CDEIS) [Срок оценки: Week 48]
  • Hospital anxiety and depression scale (HADS) [Срок оценки: Week 12 and 24]
  • The proportion of recurrences [Срок оценки: Week 48]
  • Brain functional and structural changes [Срок оценки: Week 12]
  • Plasma and intestinal TRP-KYN metabolism level [Срок оценки: Week 12]

Критерии участия

Критерии включения

  • aged 16-70;
  • patients with mild or moderate active disease (150 ≤ CDAI < 450);
  • patients who are not responsive, intolerant, dependent or refused to use at least mesalazine, glucocorticoid, immunomodulator (azathioprine, methotrexate), anti TNF alpha preparation;
  • patients were not taking medication or were only taking one or more of the following drugs: \[prednisone ≤15mg/d, azathioprine (≤1mg/kg/d), methotrexate (≤15mg/w) or mesalazine (≤4g/d)\] and prednisone was used for at least 1 month, while azathioprine, methotrexate or mesalazine was used for at least 3 months;
  • those who did not use anti-TNF alpha and other agents within 3 months before entering the study;
  • those who have never experienced acupuncture;
  • patients signing informed consent.

Критерии исключения

  • patients who are recently pregnant or in pregnancy or lactation;
  • patients with serious organic diseases;
  • patients diagnosed as psychosis;
  • patients who take antibiotics, probiotics, traditional Chinese medicine and other drugs at the same time, or who suffer from multiple diseases and need to take other drugs for a long time, and may affect the observation of the efficacy of this trial;
  • severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;
  • there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications;
  • patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year;
  • there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 2 центра
  • Shanghai Research Institute of Acupuncture and Meridian — Шанхай
  • Guona Li — Шанхай

Идентификаторы

NCT: NCT04187820 · ZYS2019-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗