NCT00065403已完成1 期
Acupuncture for Irritable Bowel Syndrome
National Center for Complementary and Integrative Health (NCCIH)1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2004年2月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 1
研究概览
简要总结
Little is known about acupuncture's efficacy for Irritable Bowel Syndrome (IBS). This trial uses a manualized acupuncture treatment format that closely follows clinical practice and allows flexibility in designing individualized treatments. In addition, a second parallel qualitative study will follow a subgroup of patients throughout the trial to explore the relationships between patients' interpretations and understandings (what anthropologists call "meaning") of irritable bowel and their response to treatment. Cortisol levels (an important stress hormone) will also be assessed.
This will be a 3-arm trial: Active acupuncture, placebo acupuncture, and wait list.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Irritable Bowel Syndrome based on Rome II criteria, including at least 12 weeks of abdominal discomfort or pain in the last 12 months with at least 2 of the following features:
- •Relief with defecation
- •Onset associated with a change in stool frequency
- •Onset associated with a change in form/appearance of stool
排除标准
- •History of severe or intractable IBS, defined as continuous, unremitting and several abdominal pain greater than 12 hours/day
- •Previous acupuncture treatment
- •Concurrent diagnosis of any bowel disturbance that would interfere with the assessment or safety of the study
- •History of laxative abuse
- •Previous abdominal surgery (uncomplicated appendectomy, hysterectomy or cholecystectomy at least 6 months prior to entry acceptable)
- •History of metabolic or inflammatory disease that may affect bowel motility, eg.g., inflammatory bowel disease, diabetes mellitus, sarcoidosis
- •Other significant illness as determined by Investigator
- •History of drug or alcohol abuse w/in 2 years;
- •Insufficient knowledge of English to complete self-assessments to participate in study
研究者
研究点 (1)
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