Urolithiasis
Conditions
Interventions
Trial Group:After percutaneous nephrolithotomy (PCNL) for renal calculi, patients in the treatment group will receive Lysimachia christinae total flavonoid capsules orally, 3 capsules per dose, three
Control group:Patients in the control group will receive no active intervention after PCNL (blank control).
Sponsors
Beijing Tsinghua Changgung Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients aged 18–70 years; those with residual renal calculi after percutaneous nephrolithotomy (PCNL) (maximum residual stone diameter [long axis] 4–8 mm); serum creatinine =30 ml/min; patients with postoperative indwelling double-J stent for 2–4 weeks; and those able to complete the study in accordance with the protocol.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, or those planning pregnancy; 2. Patients with ureteropelvic junction or ureteral malformations, strictures, or obstructions; 3. Patients with renal stones related to medullary sponge kidney, Sjögren’s syndrome, or genetic abnormalities; 4. Patients with severe urinary tract infections; 5. Patients allergic to known components of the study drug; 6. Patients with uncorrected systemic bleeding disorders, severe cardiac disease, or pulmonary insufficiency who cannot tolerate surgery; 7. Patients in whom intraoperative findings reveal residual stones that are adherent, incarcerated, or cannot be completely removed; 8. Patients with intraoperative findings of calyceal infundibular stenosis or atresia; 9. Patients with residual stones located in the renal calyx with a diameter larger than the width of the calyceal infundibulum; 10. Patients who have used stone-expelling drugs within one week (except for emergency antispasmodic or analgesic medications); 11. Subjects deemed by the investigator to have potential risks or any other factors that may interfere with participation, such as frequently changing work environments that could easily lead to loss to follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-week postoperative stone-free rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 4-week postoperative stone-free rate;Change in the maximum diameter of residual stones at 12 weeks postoperatively;Changes in liver and renal function at 4 and 12 weeks postoperatively; | — |
Countries
China
Contacts
Public ContactJianxing Li
Beijing Tsinghua Changgung Hospital
Outcome results
None listed