NCT06375382已完成不适用
Effects of Acupuncture on Abdominal Pain-related Intestinal Flora in Patients With Crohn's Disease
Shanghai Institute of Acupuncture, Moxibustion and Meridian1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2015年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Abdominal pain remission rate
研究概览
简要总结
Crohn's disease is an intestinal inflammatory disease, causing abdominal pain, diarrhea and other symptoms. The intestinal flora disorder is closely related to the occurrence and development of Crohn's disease. Acupuncture can induce remission of Crohn's disease during mild to moderate active period, improve clinical symptoms such as abdominal pain. This study is to screen the intestinal bacteria related to abdominal pain in CD, and explore the effects of acupuncture on the intestinal flora related to abdominal pain in CD patients.
详细描述
- to screen the intestinal flora associated with CD abdominal pain.
- to explore the effects of acupuncture and on abdominal pain and abdominal pain related intestinal flora in CD patients.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-75, no gender limit;
- •disease in mild and moderate active period: 150≤CDAI<450 and meet at least one of the following: serum C-reactive protein (CRP) levels ≥5mg/L, Fecal calprotectin concentration≥250μg/g or endoscopic examination shows ulcers. remission period: CDAI <150 and meet at least one of the following: serum CRP<5 mg/L, Fecal calprotectin concentration <250μg/g or endoscopic examination shows no ulcer;
- •patients were not taking medication or were only taking one or more of the following drugs: mesalazine (≤4g/d and mesalazine was used for at least 1 month), prednisone (≤15mg/d and prednisone was used for at least 1 month) and / or azathioprine (≤1mg/kg/d and azathioprine was used for at least 3 month);
- •those who have not used biologics within 3 months before entering the study;
- •those who have never experienced acupuncture;
- •those who understand and agree to participate in this study and sign the informed consent form.
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.
结局指标
主要结局
Abdominal pain remission rate
时间窗: Week 12
The abdominal pain relief rate is the ratio of the number of subjects with abdominal pain relief at the end of 12 weeks of treatment to the total number of subjects.
次要结局
- Hospital anxiety and depression scale (HADS)(Week 12)
- Safety evaluation (number of participants with abnormal routine blood tests)(Week 12)
- Safety evaluation (number of participants with abnormal Liver function tests)(Week 12)
- Crohn's disease activity index （CDAI）(Week 12)
- Inflammatory bowel disease questionnaire (IBDQ)(Week 12)
- Safety evaluation (number of participants with abnormal Renal function tests)(Week 12)
研究者
研究点 (1)
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