Clinical Study of Moxibustion for the Prevention of Hemorrhagic Cystitis After Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 303
- 试验地点
- 8
- 主要终点
- highest pain score in HC patients within 100 days of transplantation
研究概览
简要总结
This study was a prospective, multicenter, randomized controlled clinical study planned to recruit 266 hematological patients with allogeneic hematopoietic stem cell transplantation (allo-HSCT), who were randomly divided into two groups according to gender, type of transplantation, and type of primary disease. The control group was treated conventionally, and the experimental group increased moxibustion of Zhongji, Guanyuan and Qihai for 30 min qd starting on the first day after HSCT was performed until the 14th day after transplantation. Urine routine tests were performed at the time of admission, +1d, and +14d, and urine BK virus, JC virus, and adenovirus were tested at four time points, namely, +1d, +14 days, onset of hematuria symptoms, and remission of HC, respectively; routine urine tests were performed once every 7 days for all patients within 100days. For patients with Hemorrhagic cystitis (HC), daily severity grading, pain scoring, cystitis symptom scoring, use of antispasmodic and analgesic medications, and major TCM evidence were recorded with the aim of evaluating the efficacy of moxibustion in the prevention of HC in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are fully aware of the study, participate voluntarily and sign the informed consent form (ICF);
- •Age: 14-60 years;
- •Patients with pernicious blood diseases undergoing allo-HSCT using the MAC protocol or patients with severe aplastic anemia (Severe aplastic anemia; severeaplasticanimin, SAA) undergoing allo-HSCT;
排除标准
- •refuse to participate in this clinical study;
- •The corresponding skin at the moxibustion site is broken or sensitive;
- •allo-HSCT pretreated with the RIC program;
研究组 & 干预措施
Control
干预措施: Symptomatic treatment (Other)
Moxibustion
干预措施: Moxibustion (Other)
结局指标
主要结局
highest pain score in HC patients within 100 days of transplantation
时间窗: 100 days
highest pain score in HC patients within 100 days of transplantation
次要结局
- Weighted Pain Score (WPS) in HC within 100 days post-transplant(100 days)
- incidence of HC within 100 days post-transplant(100 days)
- Granulocyte implantation rate(100 days)
- Platelet implantation rate(100 days)
- Incidence of acute graft-versus-host disease(100 days)
- Cytomegalovirus (CMV)/Epstein-Barr virus (EBV) reactivation(100 days)
- Infection(100 days)
- No relapse mortality, NRM(100 days)
研究者
Yi Zhang
Physician
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology