Clinical Study of Moxibustion in the Treatment of Hemorrhagic Cystitis After Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Core Lower Urinary Tract Symptom Score
研究概览
简要总结
This study was a prospective, multicenter, single-arm clinical study planned to enroll 60 patients who developed hemorrhagic cystitis after sexually allogeneic hematopoietic stem cell transplantation Patients with hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation were given symptomatic supportive treatment combined with moxibustion covering Shenque, Zhongguo, Guanyuan, and Qihai for 30 minutes every day for 14 days and urine routine was collected every day for 14 days to assess the severity of hemorrhagic cystitis and pain scores to evaluate the effectiveness of moxibustion in treating hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients were fully aware of the study, participated voluntarily, and signed the informed consent form;
- •Age: 18-55 years old;
- •patients with hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation;
排除标准
- •refusal to participate in this clinical study;
- •broken or sensitized skin corresponding to the moxibustion site;
- •allogeneic hematopoietic stem cell transplantationpatients pretreated with the Reduced-intensity conditioning.
结局指标
主要结局
Core Lower Urinary Tract Symptom Score
时间窗: 14 days
The Core Lower Urinary Tract Symptom Score consists of 10 questions. Frequent daytime urination---0 points:\<7 times;1 point:8\~9 times;2 points:10\~14 times;3 points:\> 14 times. Nocturia---0 points:0 times/night;1 point:1 time/night;2 points: 2\~3 times/night;3 points:\> 3 times/night. The other 8 problems were urgency, dysuria, hesitancy, thin urine line, urge incontinence, stress incontinence, bladder pain, and urethral pain, which were rated as 0, 1, 2, and 3 according to their frequency (never, rarely, sometimes, and often).
次要结局
未报告次要终点
研究者
Yi Zhang
physician
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology