A Multicenter, Prospective, Randomized, Controlled Clinical Study of Ningmitai Capsule to Promote the Passage of Residual Fragments After Ureteroscopic Lithotripsy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 251
- 主要终点
- the stone expulsion time, stone-free time
研究概览
简要总结
Objective: To observe the effect of Ningmitai capsule on ureteral calculi after lithotripsy and evaluate the safety of treatment.
Study Design: A multicenter, prospective, randomized, controlled clinical study design was adopted
Interventions:
control group: Give antibiotics or diclofenac sodium suppository as needed. Ningmitai group: Oral Ningmitai Capsule (produced by Guiyang Xintian Pharmaceutical Co., Ltd.), 0.38 g/capsule, 4 capsules each time, 3 times a day.
combination group (Ningmitai plus tamsulosin).: Tamsulosin capsules, 0.2 mg/capsule, one capsule each time, once a day, were taken on the basis of Ningmitai group.
详细描述
Sample size: 230
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as upper urinary calculi by B-ultrasound, kidney and upper bladder (KUB), intravenous urogram (IVU) or computerized tomography (CT) before surgery with the ages between 20 and 70 years.
- •Having ureteral residual fragments post URL and the diameter more than 5mm.
- •The lithotripsy went smoothly with expected outcomes and without any ureteral perforation, mucous exfoliation, kidney or bladder injury, serious bleeding or any other complications.
- •Willing and able to participate in this study and comply with all scheduled visits, treatment plans and complete the clinical observations.
排除标准
- •Pregnancy, severe diabetes, or renal insufficiency.
- •Ureteral stricture and lower urinary tract obstruction.
- •Concomitant treatment with α1-receptor antagonists, or Chinese traditional medicines who can be used to relieve stranguria and expel stone, or any other treatment that might interference the efficacy evaluation.
- •Unwilling or unable to comply with the administration regimen described in the protocol, or having an incomplete profile, hence their efficacy and safety couldn't be evaluated.
- •Severe adverse events and need to withdraw from the study.
研究组 & 干预措施
Control group
Give antibiotics or diclofenac sodium suppository as needed.
干预措施: Control group (Drug)
Ningmitai capsule
Ningmitai Capsule (produced by Guiyang Xintian Pharmaceutical Co., Ltd.), 0.38 g/capsule, 4 capsules each time, 3 times a day. Course of treatment: 12 weeks
干预措施: Ningmitai capsule (Drug)
Combined group (Ningmitai plus tamsulosin)
Tamsulosin capsules, 0.2 mg/capsule, one capsule each time, once a day, were taken on the basis of Ningmitai group. Course of treatment: 12 weeks
干预措施: Combined group (Ningmitai plus tamsulosin) (Drug)
结局指标
主要结局
the stone expulsion time, stone-free time
时间窗: From baseline to 12 weeks of treatment
The diminishing or vanishing of residual fragment identified by post-surgery B-ultrasound or KUB could suggest a residual fragment expulsion. Evaluation with KUB showing the shadow of calculi disappearing completely followed by a confirmation using CT could suggest a residual fragment clearance.
次要结局
- the stone expulsion rate and stone-free rate.(From baseline to 12 weeks of treatment)