A Randomized, Placebo-Controlled, Double-Blind, Parallel Study on the Efficacy and Safety of Traditional Chinese Medicines for Chronic Constipation Residents in Long-Term Care Units
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- frequency of spontaneous bowel movement
研究概览
简要总结
The purpose of our study is to improve the problem of constipation and increase the quality of long-term care by the regimen of Chinese herb prescribed by professional doctors of 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. According to some surveys, constipation affects approximately 50% to 73% of nursing home residents. 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. Therefore constipation was labeled as "the neglected symptoms".
There is unsatisfactory effect by currently pharmacologic therapies and preventive strategies for constipation. Contrarily, they had abundant clinical experiences and medical records for constipation in traditional Chinese medicine. So we follow the worldly trend to do the research of integrative Chinese medicine and western medicine since WHO launched the first global strategy on traditional and complementary/alternative medicine (TM/CAM) to assist countries to create a stronger evidence base on the safety, efficacy and quality of the TM/CAM products and practices. The aim of our study is to improve the problem of constipation and increase the quality of long-term care by the regimen of Chinese herb prescribed by professional doctors of Chinese medicine.
The study will be performed under randomized, double-blind, placebo controlled, parallel design. The object of this study is the residents in nursing homes. After intake of Chinese herb, improving constipation and life quality, decreasing the frequency of enema or digital maneuver, minimizing the dosage of laxatives and saving the medical expenditure will be expected.
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 (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and non-pregnant women who are at least 20 years of age;
- •patients who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving study medication
- •residents in long-term care units who meet one of the following criteria in past one month:
- •MgO >= 1 tab tid 2.Dulcolax >=1 tab qd 3.concurrent use of at least two categories of laxatives 4.at least once a week of enema 5.less than three times a week of bowel movement
排除标准
- •known renal or hepatic insufficiency;
- •known colorectal cancer, anal abscess, anal fistula, anal fissure, rectocele, inflammatory bowel diseases, or gastrointestinal obstruction;
- •unknown cause of gastrointestinal bleeding or acute infection
- •history of alcohol or drug abuser
- •history of psychiatric disorders
- •women who are pregnant, as determined by a urine pregnancy test
- •use of an investigational drug (within 30days prior to enrollment)
- •known allergies to the component of study medication
结局指标
主要结局
frequency of spontaneous bowel movement
时间窗: every week
frequency of enema/digital maneuver every week
时间窗: every week
amount of rescue laxative use
时间窗: every week
次要结局
- stool consistency(every week)
- stool amount(every week)
- efficacy of treatment evaluated by care-giver(2 month)
- evaluation of safety(every week)