Ureteral Calculi
Conditions
Keywords
Ureteral calculi, Lithotripsy of ureteral calculi, Ningmitai capsule, Residual fragments
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 clinical study design was adopted Interventions: control group: Give antibiotics or diclofenac sodium suppository as needed. Ningmitai group: Oral Ningmitai Capsule (produced by Guiyang Xintian Pharmaceutical Co., Ltd.), 0.38 g/capsule, 4 capsules each time, 3 times a day. combination group (Ningmitai plus tamsulosin).: Tamsulosin capsules, 0.2 mg/capsule, one capsule each time, once a day, were taken on the basis of Ningmitai group.
Detailed description
Sample size: 230
Interventions
DRUGControl group
Give antibiotics or diclofenac sodium suppository as needed.
Oral Ningmitai Capsule (produced by Guiyang Xintian Pharmaceutical Co., Ltd.), 0.38 g/capsule, 4 capsules each time, 3 times a day for 12 Weeks.
DRUGCombined group (Ningmitai plus tamsulosin)
Tamsulosin capsules, 0.2 mg/capsule, one capsule each time, once a day, were taken on the basis of Ningmitai group for 12 Weeks.
Sponsors
Xintian Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Having ureteral residual fragments post URL and the diameter more than 5mm. 3. The lithotripsy went smoothly with expected outcomes and without any ureteral perforation, mucous exfoliation, kidney or bladder injury, serious bleeding or any other complications. 4. Willing and able to participate in this study and comply with all scheduled visits, treatment plans and complete the clinical observations.
Exclusion criteria
1. Pregnancy, severe diabetes, or renal insufficiency. 2. Ureteral stricture and lower urinary tract obstruction. 3. 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. 4. 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. 5. Severe adverse events and need to withdraw from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the stone expulsion time, stone-free time | From baseline to 12 weeks of treatment | The diminishing or vanishing of residual fragment identified by post-surgery B-ultrasound or KUB could suggest a residual fragment expulsion. Evaluation with KUB showing the shadow of calculi disappearing completely followed by a confirmation using CT could suggest a residual fragment clearance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the stone expulsion rate and stone-free rate. | From baseline to 12 weeks of treatment | The diminishing or vanishing of residual fragment identified by post-surgery B-ultrasound or KUB could suggest a residual fragment expulsion. Evaluation with KUB showing the shadow of calculi disappearing completely followed by a confirmation using CT could suggest a residual fragment clearance. |
Outcome results
None listed