Chinese and Western Medicine Collaborative Studies on Palliative Cancer Patients With Constipation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Global symptom improvement (improved / same / worse)
研究概览
简要总结
It is a double-blinded, randomized, placebo-controlled trial for advanced cancer patients with constipation. 60 patients will be randomly assigned to have individualized herbal intervention (treatment group) or placebo (control group) in 1:1 ratio. For the treatment group, MaZiRenWan 10g plus HuangQi 20g are chosen as the core prescription. Furthermore, six herbal granules can be added according to the syndrome differentiated for individual participant. Placebo is made from dextrin (76.03%), tea essence (23.61%), gardenin (0.02%), and caramel (0.34%) to achieve color, smell, taste, and texture comparable to the herbal granules. Patients are instructed to dissolve the granules in 150ml of hot water, twice daily for two weeks. The primary end point is the global symptom improvement. Secondary outcome measures include stool frequency, stool form, use of rescue herbal granules, constipation visual analogue scale (CVAS) (0=none to 7=most severe) and individual assessment of constipation related symptoms. For the safety profiles of herbal intervention, the important adverse events reported and clinical laboratory evaluations of liver and renal function are determined.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severity of constipation > 3 points (an 8-point scale from 0 to 7)
- •Palliative Performance Scale ≥60%
- •Relatively stable liver and renal function within 3 months
- •Patients who can read and speak Chinese
排除标准
- •Inability to communicate
- •Presence of a colostomy, or gastrointestinal obstruction
- •Presence of loose or watery stool (Bristol stool scale 6-7) or bowel movement > 3/day under routine laxative treatment
- •History of Chinese herbal medicine allergies
- •Estimated life expectancy less than 1 month
研究组 & 干预措施
Chinese herbal medicine
MaZiRenWan 10g plus HuangQi 20g are chosen as the core prescription. Furthermore, six herbal granules can be added according to the syndrome differentiated for individual participant. They are ShuDiHuang 15g and Danggui 10g for deficiency of blood, Maidong 15g and ShengDiHuang 10g for deficiency of Yin, and RouCongRong 15g and Niuxi 10g for deficiency of Yang.
干预措施: Chinese herbal medicine (Drug)
Placebo
Placebo is made from dextrin (76.03%), tea essence (23.61%), gardenin (0.02%), and caramel (0.34%) to achieve color, smell, taste, and texture comparable to the herbal granules.
干预措施: Placebo (Drug)
结局指标
主要结局
Global symptom improvement (improved / same / worse)
时间窗: 2 weeks
Participants are asked to rate their impression of change in constipation symptoms in comparison with their baseline, with scores from 0 to 6 represents markedly worse or better at the respective extremes. The response categories are collapsed to simply "improved" for score 4-6, "same" for score 3, or "worse" for score 0-2.
次要结局
- Number of bowel movement (times/day)(2 weeks)
- Extra laxatives used (times/week)(2 week)
- Stool form(2 weeks)
- Constipation visual analogue scale(2 weeks)
- Constipation related symptoms(2 weeks)
- Blood urea level (mmol/L)(2 weeks)
- Adverse events(2 weeks)
- Blood creatinine level (umol/L)(2 weeks)
- Serum glutamic pyruvic transaminase(SGPT) Level (U/L)(2 weeks)
- Serum Glutamic Oxaloacetic Transaminase (SGOT) Level (U/L)(2 weeks)
研究者
ZhaoXiang Bian
Chair Professor, Director
Hong Kong Baptist University