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临床试验/NCT01696838
NCT01696838已完成不适用

Efficacy of Acupuncture and Moxibustion Treatment in Patients With Quiescent Crohn's Disease:Evaluation With Functional Magnetic Resonance Imaging(fMRI)

Shanghai Institute of Acupuncture, Moxibustion and Meridian1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2012年9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
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

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)

研究者

发起方
Shanghai Institute of Acupuncture, Moxibustion and Meridian
申办方类型
Other
责任方
Sponsor

研究点 (1)

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