Changhua Christian Hospital
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in EORTC QOL-C30 at four weeks
研究概览
简要总结
Using Shen-Mai-San for cancer patients undergoing chemotherapy or radiotherapy could help these people improve the quality of life.
详细描述
Shen-Mai-San could improve fatigue, general weakness, neutropenia for patients under going chemotherapy or radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postoperative patients with histologically confirmed cancer within 3 years and undergoing chemotherapy or radiotherapy
- •age above 18 years old
- •signed informed consent
- •ability to read Chinese, ability for oral intake.
排除标准
- •being pregnancy
- •on breast feeding
- •completed chemotherapy or radiotherapy
- •brain metastasis with Eastern Cooperative Oncology Group (ECOG) performance status of two to four
- •delusion or hallucination
- •acute infection
- •received medications for other clinical trials.
研究组 & 干预措施
Shen-Mai San
Shen mai san is composed of three herb medicines, Ginseng radis, Liriope spicata, and Schizandrae fructus and was manufactured into concentrated herbal extract and packed with 0.5g per capsule and labeled by Sun-Ten pharmaceutical company in Taiwan with good manufacturing practice (GMP).
干预措施: Shen-Mai San (Drug)
starch
Starch in the same granule as intervention group for this double-blind trial
干预措施: Starch (Drug)
结局指标
主要结局
Change from baseline in EORTC QOL-C30 at four weeks
时间窗: baseline and four weeks
次要结局
- Change from baseline in BUN, Creatinine, GOT, GPT at four weeks(baseline and four weeks)
- Change from baseline in Heart rate variability at four weeks(baseline and four weeks)
研究者
Chia-Yun Chen
MD
Changhua Christian Hospital