Status:
COMPLETED
Clinical Study of Ningmitai Capsule on Promoting the Passage of Residual Fragments After Ureteroscopic Lithotripsy
Lead Sponsor:
Xintian Pharmaceutical
Conditions:
Ureteral Calculi
Eligibility:
All Genders
20-70 years
Phase:
PHASE4
Brief Summary
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 clin...
Detailed Description
Sample size: 230
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 2 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2019
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT06105827
Start Date
October 2 2016
End Date
April 25 2019
Last Update
October 30 2023
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