Randomised Controlled Trial of Acupuncture for Patients With Chronic Constipation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- score of questionnaire of constipation symptoms
研究概览
简要总结
Since there have been few advances for constipation in laxative treatment in the last 50 years, this study is designed to evaluate the efficacy and safety of acupuncture for patients with chronic constipation based on the theory of traditional Chinese Medicine.
详细描述
Although many people regard regular defecation as important factor to maintain healthy, constipation is still a common problem in general population. Because the symptoms cause serious impairment of life quality, laxatives are commonly prescribed for people and over prescribing of laxatives is also common. Despite the large sums spent on laxatives, there have been few advances in laxative treatment in the last 50 years and there have been minimal research addressing the problem.
Since there is unsatisfactory effect by current pharmacologic therapies and preventive strategies, we look forward to the practice of traditional Chinese medicine, which had abundant clinical experiences and medical records in the past of thousands years ago. Therefore we aim to do the research to create the evidence of acupuncture on the safety, efficacy and quality of life for chronic constipation.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •men or non-pregnant women who are at least 20 years old
- •who meet any one of the following three criteria: 1.the one who meets RomeIII criteria; 2.at least once a week of enema/suppository in past three months; 3.laxative use in more than half time of last three months
排除标准
- •known colorectal cancer, anal abscess, anal fissure, rectocele, inflammatory bowel disease, megacolon or mechanical bowel obstruction
- •unknown cause of gastrointestinal bleeding or acute infection
- •history of alcohol or drug abuser
- •women who are pregnant, as determined by a urine pregnancy test
- •history of adverse reaction to (electro)acupuncture
- •received herb or acupuncture therapy within one month prior to enrollment
结局指标
主要结局
score of questionnaire of constipation symptoms
时间窗: every month
次要结局
- score of questionnaire of quality of life(every month)
- amount of laxative use(every week)
- frequency of enema/suppository use/digital maneuver(every week)
- stool amount(every week)
- stool consistency(every week)
- overall efficacy(2 month)
- safety (adverse event)(every week)
- frequency of spontaneous bowel movement(every week)