NCT02559037已完成不适用
Effect of Acupuncture on Maintaining Active Crohn's Disease Intestinal Homeostasis Via Intestinal Microbiota and Peripheral Immunity: a Randomized Controlled Trial
Shanghai Institute of Acupuncture, Moxibustion and Meridian1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2015年4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
- 66
- 试验地点
- 1
- 主要终点
- The proportion of patients with clinical remission
研究概览
简要总结
The purpose of this study is to observe the efficacy and safety of acupuncture and moxibustion for Crohn's disease and the regulation mechanism of intestinal microbiota and peripheral immunity.
详细描述
- A randomized controlled trial.
- Acupuncture and moxibustion treatment, placebo control.
- To observe the efficacy and safety of acupuncture and moxibustion treatment versus placebo controlled for Crohn's disease.
- To observe the effect on the regulation of intestinal microbiota in Crohn's disease.
- To observe the effect on the regulation of peripheral immunity in Crohn's disease.
- To observe the effect on the regulation of brain function and structure in Crohn's disease.
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
- •meet the diagnostic criteria of Crohn's disease;
- •age 16-70 years old;
- •patients with mild or moderate disease (150<CDAI<450) and evidence of active inflammation: serum C-reactive protein concentration ≥5 mg/L, fecal calprotectin concentration ≥250 μg/g, or obvious endoscopic evidence of ulcerations during the screening period of past 4 weeks;
- •patients who were not responsive, intolerant, dependent, or refused to use any one of the following medications: mesalazine, glucocorticoid, immunomodulator (azathioprine, methotrexate), and anti-TNF-α agents;
- •did not take or take one or more of the following drugs: prednisone <15 mg/d for at least one month, azathioprine (<1 mg/kg/d), methotrexate (<15 mg/week), or mesalazine (<4 g/d) for at least 3 months;
- •no history of use of anti-TNF-alpha or other biological agents within 3 months immediately preceding the enrolment in the study;
- •no previous history of receiving acupuncture;
- •provision of written informed consent.
排除标准
- •Pregnant or lactating women, and those desirous of conceiving in the near future;
- •patients with severe organic diseases;
- •patients with mental illness;
- •patients receiving antibiotics, probiotics, prebiotics, traditional Chinese medicine, or other drugs;
- •patients with multiple comorbid conditions that require long-term therapy with drugs, which may affect the outcome measures;
- •patients with severe extraintestinal manifestations, such as severe skin diseases, eye diseases, or thromboembolic diseases;
- •severe intestinal fistula, abdominal abscess, intestinal stenosis and intestinal obstruction, perianal abscess, gastrointestinal bleeding, bowel perforation, or other complications;
- •patients with short bowel syndrome;
- •patients with a history of abdominal or gastrointestinal surgery in the past six months;
- •patients with skin diseases or defects at the sites of acupuncture that prevents the application of acupuncture.
结局指标
主要结局
The proportion of patients with clinical remission
时间窗: Week 12
Defined as Crohn's disease activity Index (CDAI) \< 150 and decrease \> 70
次要结局
- the mean change of CDAI from baseline(Week 12, 24, 36 and 48)
- Quality of life on the Inflammatory Bowel Disease Questionnaire (IBDQ)(Week 12 and 24)
- The proportion of clinical recurrences(Week 24，36 and 48)
- The proportion of patients with clinical response(Week 12, 24, 36 and 48)
- The proportion of patients with clinical remission(Week 24, 36 and 48)
- Safety evaluation (Number of participants with treatment-related adverse events as assessed by CTCAE v4.0)(Week 12, 24，36 and 48)
- Psychological factors on the Hospital anxiety and depression scale (HADS)(Week 12 and 24)
- The mean change of Crohn's disease endoscopic index of severity (CDEIS)(Week 48)
- Fecal calprotectin tests for disease activity(Week 12)
- Histological scores for pathogenic manifestations(Week 48)
- Subgroup analysis of the main outcome measure(Week 12)
- Laboratory tests for disease activity(Week 12, 24, 36 and 48)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Effect of Acupuncture on Quiescent Crohn's DiseaseInflammatory Bowel DiseasesCrohn DiseaseNCT04198831Shanghai Institute of Acupuncture, Moxibustion and Meridian84
暂停
不适用
Effect of Acupuncture on Patients With Crohn's Disease in RemissionInflammatory Bowel DiseasesCrohn DiseaseNCT04211129Shanghai Institute of Acupuncture, Moxibustion and Meridian60
招募中
不适用
Acupuncture Reduces Relapse in Patients With Crohn's Disease: a Superiority TrialCrohn's Disease RelapseInflammatory Bowel DiseasesNCT06553053Shanghai Institute of Acupuncture, Moxibustion and Meridian106
招募中
不适用
Effect of Acupuncture on Mild to Moderate Active Crohn's DiseaseIntestinal DisorderInflammatory Bowel DiseasesCrohn DiseaseNCT04187820Shanghai Institute of Acupuncture, Moxibustion and Meridian60
招募中
不适用
Effect of Acupuncture on Crohn's disease: A Multi-center Randomized Controlled TrialCrohn's diseaseITMCTR2000003602Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine