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Clinical Study of Ningmitai Capsule on Promoting the Passage of Residual Fragments After Ureteroscopic Lithotripsy | Clinical Trials | Clareo Health

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

A Multicenter, Prospective, Randomized, Controlled Clinical Study of Ningmitai Capsule to Promote the Passage of Residual Fragments After Ureteroscopic Lithotripsy

NCT06105827•Xintian Pharmaceutical

View on ClinicalTrials.gov

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

Eligibility

Age

20 - 70 years

Sex

ALL

Healthy Volunteers

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.

Key Dates

Start Date

October 2, 2016

Primary Completion Date

April 25, 2019

Completion Date

April 25, 2019

Last Updated

October 30, 2023

Enrollment

251

ACTUAL participants

Conditions

Ureteral Calculi

Interventions

Control group

DRUG

Ningmitai capsule

DRUG

Combined group (Ningmitai plus tamsulosin)

DRUG

Study of Ketorolac Versus Opioid for Pain After Endoscopy

NCT03888144

Kidney CalculiUreteral Calculi

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COMPLETEDNA

Comparison of Ureteroscopic Lithotripsy and Laparoscopic Ureterolithotomy for the Treatment of Unilateral Upper Ureteral Stone

NCT07197385

Ureteral CalculiUrolithiasis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 30, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study of Ketorolac Versus Opioid for Pain After Endoscopy

Comparison of Ureteroscopic Lithotripsy and Laparoscopic Ureterolithotomy for the Treatment of Unilateral Upper Ureteral Stone

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