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A Randomized Controlled Trial on the Efficacy and Safety of Urinary Stone Relief Pills Combined with Tamsulosin in the Treatment of Upper Urinary Tract Stones (Including Postoperative Residual Stones)

A Randomized Controlled Trial on the Efficacy and Safety of Urinary Stone Relief Pills Combined with Tamsulosin in the Treatment of Upper Urinary Tract Stones (Including Postoperative Residual Stones)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110177
Enrollment
Unknown
Registered
2025-10-09
Start date
2025-10-11
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney stones

Interventions

Experimental group:Take Urostone Tong Pills orally twice a day, 7 grams each time
at the same time, take two 0.2 mg tablets of Tamsulosin Hydrochloride Sustained-release Capsules
Control group:Take 0.2 mg of Tamsulosin Hydrochloride Sustained-release Capsules twice daily, each time two capsules

Sponsors

Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Voluntarily sign the informed consent form, understand this study and be willing to follow and be capable of completing all the trial procedures; 2. No gender restrictions, aged between 18 and 75 years (inclusive of the boundary values); 3. Patients with upper urinary tract calculi with a diameter of 4-6mm confirmed by abdominal plain radiography (KUB), ultrasound or non-contrast computed tomography (CT), or who have undergone minimally invasive stone surgery or extracorporeal shock wave lithotripsy, but with residual stone fragments that may cause urinary tract obstruction.

Exclusion criteria

Exclusion criteria: 1. Patients with severe ureteral calculi entrapment; 2. Patients suspected of having stones in the lower calyx of the kidney; 3. Severe hydronephrosis; 4. Patients with severe urinary tract infection, pyonephrosis, and renal insufficiency, defined as glomerular filtration rate = 180 mmHg, or diastolic blood pressure >= 110 mmHg), hypotension (systolic blood pressure 8.5%); 8. Patients with a previous history of ipsilateral ureteral surgery or spontaneous stone expulsion; 9. Patients with a history of orthostatic hypotension or at high risk of it; 10. Patients known to be allergic to the known components of the investigational drug; 11. Pregnant women or those preparing for pregnancy within 6 months, and lactating women; 12. Patients who participated in other clinical trials within 30 days before screening; 13. Patients judged by the investigator to be uncooperative due to mental illness or cognitive impairment; 14. Patients considered not suitable to participate in this clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
The situation of stone excretion;

Countries

China

Contacts

Public ContactYu Xiao

Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology

1605146747@qq.com+86 192 6844 4174

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026