NCT04187820招募中不适用
Effect of Acupuncture on Crohn's Disease Via the Regulation of Trp-kyn Metabolism in Brain-gut Axis
Shanghai Institute of Acupuncture, Moxibustion and Meridian2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Clinical remission
研究概览
简要总结
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
详细描述
- Effect of acupuncture on symptoms of CD
- Effect of acupuncture on brain functional activity of CD
- Effect of acupuncture on intestinal and plasma TRP-KYN metabolism level of CD
- Screen the brain image markers of acupuncture in the treatment of CD
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Clinical remission
时间窗: Week 12
Crohn's disease activity index （CDAI）less than 150 and decreased more than 70
次要结局
- Clinical remission(Week 24, 36 and 48)
- Clinical response(Week 12, 24, 36 and 48)
- Crohn's disease activity index （CDAI）score(Week 12, 24, 36 and 48)
- Crohn's disease endoscopic index of severity (CDEIS)(Week 48)
- Brain functional and structural changes(Week 12)
- Inflammatory bowel disease questionnaire (IBDQ)(Week 12 and 24)
- Hospital anxiety and depression scale (HADS)(Week 12 and 24)
- The proportion of recurrences(Week 48)
- laboratory test(Week 12, 24, 36 and 48)
- Plasma and intestinal TRP-KYN metabolism level(Week 12)
研究者
研究点 (2)
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