NCT04211129暂停不适用
Effect of Acupuncture on Crohn's Disease Via the Regulation of Trp-kyn Metabolism in Brain-gut Axis
Shanghai Institute of Acupuncture, Moxibustion and Meridian4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Brief Fatigue Inventory (BFI-C)
研究概览
简要总结
To observe the therapeutic effect of acupuncture on Crohn's disease in remission and its influence of brain functional activity
详细描述
- Effect of acupuncture on symptoms （functional gastrointestinal symptoms, Fatigue, insomnia, depression, anxiety and perceived stress）of CD
- Effect of acupuncture on brain functional activity of CD
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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 in remission (CDAI < 150);
- •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 TNF alpha and other preparations 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
Brief Fatigue Inventory (BFI-C)
时间窗: Week 12
The mean change in BFI-C from baseline. The higher the score, the worse the condition. Greater than 0, the upper limit is 90.
次要结局
- Inflammatory bowel disease questionnaire (IBDQ)(Week 12, 24 and 52)
- The proportion of recurrences(Week 52)
- The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)(Week 12, 24,52)
- Hospital anxiety and depression scale (HADS)(Week 12, 24 and 52)
- Brief Fatigue Inventory (BFI-C)(Week 24,52)
- Crohn's disease activity index （CDAI）score(Week 12, 24,36,48,52)
- Generalized Anxiety Disorder (GAD-7)(Week 12, 24 and 52)
- Brain functional and structural changes(Week 12)
- Laboratory tests(Week 12, 24, 36, and 52)
- Patient Health Questionnaire Depression Scale (PHQ-9)(Week 12, 24 and 52)
- Colonoscopy or small bowel MR evaluation(Week 52)
研究者
研究点 (4)
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