Efficacy of Acupuncture and Moxibustion Treatment in Patients With Active Crohn's Disease and Its Regulation Mechanism to the Immune Homeostasis Mediated by Th17/Treg Cells
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- CDAI
研究概览
简要总结
The purpose of this study is to determine whether acupuncture or moxibustion therapies are effective in the treatment of active Crohn's disease. meanwhile, we are aim to observe the content of Inflammatory factors and Neurotransmitter before and after acupuncture and moxibustion therapy.
详细描述
The purpose of this study is to determine whether acupuncture or moxibustion therapies are effective in the treatment of active Crohn's disease. meanwhile, we are aim to observe the content of Inflammatory factors and Neurotransmitter before and after acupuncture and moxibustion therapy.
Through treating active Crohn's disease by acupuncture and moxibustion therapies for 12 weeks, we are aim to observe the efficiency and the probably change of Inflammatory factors and Neurotransmitter of colonic mucosa and we may elucidate the mechanism of the efficiency of acupuncture and moxibustion therapy.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-70 years;
- •Crohn's Disease Activity Index [CDAI]>150 and <450;
- •not taking any medication or taking salicylates, prednisone ( dose≤ 15mg and at least have taken a month ), after entering the study the dose remained constant;
- •Not taking immunosuppressive agents or use " with " biological preparations within 3 months prior to entering the study
- •signing a written informed consent form.
排除标准
- •Severe Crohn's disease patients or patients in remission ( CDAI > 450 or < 150 );
- •The pregnancy or lactation period patients ;
- •patients associated with heart, brain, liver, kidney and hematopoietic system disease;
- •The psychiatric patients;
- •Patients with other serious diseases.
结局指标
主要结局
CDAI
时间窗: 2 years
Crohn's Disease Activity Index
次要结局
- IBDQ(2 years)
- Inflammatory factors(2 years)
- Neurotransmitter(2 years)