A Clinical Study on Bushen Huoxue Simiao Formula for Nourishing the Kidneys and Promoting Blood Circulation to Improve Postoperative Complications of Upper Urinary Tract Stones
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Urinary System Symptom Questionnaire (USSQ).
研究概览
简要总结
This study examines the efficacy and safety of Bushen Huoxue Simiao formula for tonifying the kidneys and promoting blood circulation in treating postoperative complications of upper urinary tract stones, thereby providing evidence-based medical evidence and treatment strategies for clinical practice.
详细描述
1. Study Design and Methods 1.1 Research Method A multicenter, open-label study design was used. 1.2 Source of Participants The cases in this clinical observation were recruited from the Department of Urology at the Fourth Affiliated Hospital of Zhejiang University School of Medicine, Yiwu Traditional Chinese Medicine Hospital, and Fujian Provincial People's Hospital. All patients were diagnosed with upper urinary tract stones (including kidney stones and ureteral stones) and underwent ureteroscopic holmium laser lithotripsy and stone removal. A 4.7F, 28 cm double-J stent was left in place postoperatively, and patients returned to the hospital 4 weeks later for stent removal. Participants were randomly assigned to either the "Four-Ingredient Formula for Nourishing the Kidneys and Promoting Blood Circulation" group or the control group using a random number table. Informed consent was obtained from all enrolled participants.
1.3 Participant Selection and Exclusion Criteria 1.3.1 Western Medicine Diagnostic Criteria According to the definitions of renal stones and ureteral stones in *Practical Urology*, a diagnosis of renal stones or ureteral stones is made based on the presence or absence of stone-related symptoms and signs, in conjunction with the patient's medical history and the results of a urinary tract color Doppler ultrasound and non-contrast abdominal CT scan performed after admission.
1.3.2 Traditional Chinese Medicine Diagnostic Criteria
Based on clinical manifestations, in accordance with the *Guidelines for Clinical Research on New Traditional Chinese Medicines* and the *General Principles for Clinical Research on New Traditional Chinese Medicines*-both formulated in accordance with the National Standards of the People's Republic of China-and with reference to the views of various scholars, the following criteria have been established:
Kidney Deficiency with Blood Stasis and Damp-Heat Syndrome Principal Symptoms: Distending, aching, stabbing, or localized pain in the lower back and abdomen, occurring intermittently and worsening with exertion; may be accompanied by hematuria, vomiting, or painful and difficult urination; or may be asymptomatic.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the Western medicine diagnostic criteria: Patients who need lithotripsy surgery and have a double J stent (4.7F, 28 cm) placed after surgery; plain film of kidney and upper bladder indicates normal position of ureteral stent and no need for stage II surgery.
- •Meet the Traditional Chinese Medicine (TCM) diagnostic criteria.
- •Aged between 18 and 80 years old (inclusive).
- •Voluntary participation with signed informed consent.
排除标准
- •Patients with renal insufficiency stage 4 or 5, or acute renal failure.
- •Secondary factors confirmed by examination, such as systemic lupus erythematosus or drug-induced kidney damage.
- •Does not meet the diagnosis of upper urinary tract stones.
- •Cases not within the scope of drug action.
- •Long-term use of other relevant therapeutic drugs, or inability to stop medication immediately.
- •Late-stage deformity, disability, or loss of labor ability.
- •Complicated with severe primary diseases of heart, brain, liver, hematopoietic system, endocrine system, etc., or mental illness.
- •Pregnant or lactating women.
- •Patients in critical condition.
- •Other conditions deemed unsuitable for enrollment by the researchers.
结局指标
主要结局
Urinary System Symptom Questionnaire (USSQ).
时间窗: Baseline and 4 weeks after treatment
The Urinary System Symptom Questionnaire (USSQ) is used to assess urinary symptoms and quality of life. Score Range: The total score ranges from \[0\] to \[100\] .Interpretation: Higher scores indicate more severe urinary symptoms and worse quality of life.
次要结局
- Incidence of Abnormal Urinalysis Results(Baseline and 4 weeks after treatment)
- Serum Creatinine (SCr) Level(Baseline and 4 weeks after treatment)
- Blood Urea Nitrogen (BUN) Level(Baseline and 4 weeks after treatment)