A Study on the Efficacy and Safety of Ningmitai Capsules in Treating Patients With Upper Urinary Tract Stones After Extracorporeal Shock Wave Lithotripsy

1. 18 - 70 years (inclusive of the threshold value);
2. Suffering from a single non-transparent X-ray kidney stone or ureteral stone, which was confirmed through abdominal CT scan before the operation, with the longest diameter ranging from 6 to 20 mm, and the CT value being less than 1000 HU;
3. Evaluated to be planned for single extracorporeal shock wave lithotripsy (ESWL) treatment, and confirmed by KUB X-ray examination 3 ± 1 days after ESWL that the maximum residual stone length in the upper urinary tract is greater than 2 mm and less than or equal to 7 mm;
4. Voluntary participant and signed the informed consent form.

Exclusion Criteria:

1. Patients with the target stones located in the lower calyx of the kidney, the bladder or the urethra;
2. Patients with stone entrapment, infectious stones or antler-shaped stones;
3. Patients confirmed to have stones by imaging examination;
4. Patients who, based on the investigator's judgment, are expected to require secondary ESWL treatment due to residual stones during the study period, or will undergo surgical treatments such as physical vibration lithotripsy, ureteroscopy lithotripsy, percutaneous nephroscope lithotripsy, laparoscopic or open surgery lithotripsy, etc. during the study period;
5. Patients who have undergone ESWL, physical vibration lithotripsy, ureteroscopy lithotripsy, percutaneous nephroscope lithotripsy, laparoscopic or open surgery lithotripsy, etc. for ureter or kidney surgery within the past 3 months;
6. Patients with indwelling ureteral stents;
7. Patients with abnormal urinary tract anatomical structures that affect stone expulsion, such as known or suspected ureteropelvic junction obstruction, ureteral stenosis, urinary tract malformations, or previous history of urinary tract reconstruction surgery, scar adhesion, etc.;
8. Patients with bladder outlet obstruction or neurogenic bladder;
9. Patients with abnormal renal collecting system anatomy, such as isolated kidney, horseshoe kidney, ectopic kidney, transplanted kidney, etc.;
10. Patients with severe (grade III) hydronephrosis or a clinically significant renal cyst on the affected side, such as renal parenchymal cysts compressing the renal collecting system, or renal cysts with a risk of rupture or bleeding as determined by the investigator during ESWL;
11. Patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of the reference range (ULN), or serum creatinine (Scr) > 1.5×ULN, or renal insufficiency on the affected side;
12. Patients with severe obesity (BMI > 37.5 kg/m2) or patients with severe skeletal deformities that are judged by the investigator to affect stone localization;
13. Patients with poorly controlled diabetes (fasting blood glucose > 10.0 mmol/L or glycosylated hemoglobin > 8.0%) or hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg) or uncorrected coagulation dysfunction;
14. Patients with untreated urinary tract infections, or those with fever or clear laboratory infection evidence at the time of screening, defined as: body temperature ≥ 38.0°C, or white blood cell count > 10×10⁹/L;
15. Patients with renal aneurysm and/or abdominal aortic aneurysm;
16. Patients with other severe systemic diseases and functional impairments, as determined by the investigator to be unsuitable for inclusion, including but not limited to respiratory system diseases, circulatory system diseases, endocrine system diseases, digestive system diseases, urinary system diseases, immune-related diseases and hematological diseases, severe neurological or mental diseases, etc.;
17. Patients who used study-contraindicated concomitant drugs within 1 week before randomization (α receptor blockers, calcium channel blockers, PDE5 inhibitors, progesterone, hydrochlorothiazide tablets, thiazide diuretics, basic citrate, allopurinol, febuxostat, acetohydroxamic acid capsules, except for the investigational drugs, other drugs with therapeutic effects on urinary stones or with diuretic, litholytic, stone expulsion-related functions) or other drugs with urinary system stone-lowering effects (except for emergency spasm-relieving, anti-inflammatory, analgesic medications);
18. Patients known to be allergic or intolerant to the investigational drug or its components;
19. Pregnant or lactating women, or those with a fertility plan within the past 3 months;
20. Patients suspected or confirmed to have a history of alcohol or drug abuse;
21. Patients who have participated in other clinical trials of drugs or medical devices within the past month;
22. Patients considered not suitable for inclusion by the investigator.