Overview

Clinical Study of Ningmitai Capsule on Promoting the Passage of Residual Fragments After Ureteroscopic Lithotripsy

Status:
Completed
Trial end date:
2019-04-25
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Xintian Pharmaceutical
Treatments:
Diclofenac
Tamsulosin
Criteria
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.