Efficacy of Acupuncture and Moxibustion Treatment in Patients With Quiescent Crohn's Disease:Evaluation With Functional Magnetic Resonance Imaging(fMRI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 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 Crohn's disease. Meanwhile, the investigators aim to evaluate the efficacy by functional magnetic resonance imaging.
详细描述
The purpose of this study is to determine whether acupuncture or moxibustion therapies are effective in the treatment of Crohn's disease. meanwhile, the investigators aim to evaluate the efficacy by functional magnetic resonance imaging.
Through treating quiescent Crohn's disease by electroacupuncture or moxibustion therapies for 12 weeks, Compare the different brain activation by the different therapies and observe the correlation between brain activation and efficacy.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18-50 years;
- •right-handed;
- •clinical remission (Crohn's Disease Activity Index [CDAI]≤150) for at least 6 months prior to the study;
- •C-reactive protein(CRP)<10 mg/l;
- •erythrocyte sedimentation rate (ESR) <20 mm/h
- •signing awritten informed consent form.
排除标准
- •use of corticosteroids and psychotropic medications in the previous 30 days;
- •current or prior history of neurological or psychiatric disease based
- •on physicians' examination and questionnaires;
- •current or prior history of neurosurgery, head injury, cerebrovascular
- •insult, or brain trauma involving loss of consciousness;
- •learning disability;
- •claustrophobia;
- •presence of metallic implants in the body;
- •being pregnant or during lactation.
结局指标
主要结局
CDAI
时间窗: 1 year
Crohn's Disease Activity Index
次要结局
- IBDQ(1 year)
- fMRI(1 year)
- Inflammatory factors(1 and a half years)
- Neurotransmitter(1 and a half years)