Acupuncture Reduces Relapse in Patients With Crohn's Disease: a Superiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- The proportion of recurrences
研究概览
简要总结
The aim of this study was to further improve the clinical efficacy of acupuncture in delaying the clinical recurrence of CD and to explore the efficacy mechanism of acupuncture efficacy enhancement.
详细描述
Acupuncture has been proven to be an effective and safe treatment for CD. In this trial, based on previous studies, which mainly treated CD from the perspective of spleen and stomach tonification, we explored the therapeutic effect of acupuncture in treating CD from the perspective of tonifying the Shaoyang pivot mechanism to enhance the therapeutic effect.Brain-gut axis dysfunction is one of the important pathogenic mechanisms of CD. This trial attempted to explore the therapeutic targets and efficacy mechanisms of acupuncture to enhance CD by analysing brain-gut axis multi-pathway indicators.
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 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with clinical diagnosis consistent with CD;
- •aged 16-75;
- •patients in remission (CDAI < 150 and CRP < 5mg/l, or Faecal calprotectin < 50μg/g, or no ulcer under endoscopy);
- •patients with frequent disease recurrences (≥2) in the past years;
- •patients were not taking medication or were only taking one or more of the following drugs: [mesalazine (≤4g/d), prednisone (≤15mg/d), azathioprine (≤1mg/kg/d)] and prednisone and mesalazine were used for at least 1 month, while azathioprine was used for at least 3 months; or those who had poor response or loss of response to biological preparations (anti-TNF-α, IL-12p40, α4β7);
- •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 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.
研究组 & 干预措施
Experimental Group
Receiving acupuncture with the function of "harmonizing Shaoyang, nourishing spleen and kidney with warmth"
干预措施: "Harmonizing Shaoyang, nourishing spleen and kidney with warmth" Acupuncture Group (Other)
Control group
Receiving acupuncture group with the function of "nourishing spleen and kidney with warmth"
干预措施: "Nourishing spleen and kidney with warmth" Acupuncture Group (Other)
结局指标
主要结局
The proportion of recurrences
时间窗: Week 52
Defined as CDAI \> 150 and increase ≥ 70 points, or emergency, hospitalization and surgical events due to worsening of CD conditions, or need to adjust drug to control disease condition.
次要结局
- Inflammatory bowel disease questionnaire (IBDQ)(Week 0, 12, 24, 36 and 52)
- Colonoscopy or small bowel MR evaluation(Week 0 and 52)
- First laboratory tests(Week 0, 6, 12, 24, 36 and 52)
- Time of recurrences(Week 52)
- Crohn's disease activity index （CDAI）score(Week 0, 6, 12, 24, 36 and 52)
- Patient Reported Outcome （PRO2）(Week 0, 6, 12, 24, 36 and 52)
- Blind questionnaire(Week 6 and 12)
- Hospital anxiety and depression scale (HADS)(Week 0, 12, 24, 36 and 52)
- The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)(Week 0, 12, 24, 36 and 52)
- Expectation of acupuncture treatment(Week 0)
- Number of recurrences(Week 52)
- Second laboratory tests(Week 0, 6, 12, 24, 36 and 52)
- Third laboratory tests(Week 0, 6, 12, 24, 36 and 52)