Clinical Study of Ningmitai Capsule on Promoting the Passage of Residual Fragments After Ureteroscopic Lithotripsy (3)

October 23, 2023 updated by: Xintian Pharmaceutical

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sample size: 230

Study Type

Interventional

Enrollment (Actual)

251

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
Give antibiotics or diclofenac sodium suppository as needed.
Drug: Control group
Give antibiotics or diclofenac sodium suppository as needed.
Other Names:
  • diclofenac sodium
Experimental: Ningmitai capsule
Ningmitai Capsule (produced by Guiyang Xintian Pharmaceutical Co., Ltd.), 0.38 g/capsule, 4 capsules each time, 3 times a day. Course of treatment: 12 weeks
Drug: Ningmitai capsule
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.
Experimental: Combined 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. Course of treatment: 12 weeks
Drug: Combined 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.
Other Names:
  • Ningmitai plus tamsulosin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the stone expulsion time, stone-free time
Time Frame: 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.
From baseline to 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the stone expulsion rate and stone-free rate.
Time Frame: 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.
From baseline to 12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xintian Pharmaceutical

Investigators

  • Principal Investigator: Yuan Jingdong, Doctor, Wuhan First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2016

Primary Completion (Actual)

April 25, 2019

Study Completion (Actual)

April 25, 2019

Study Registration Dates

First Submitted

October 23, 2023

First Submitted That Met QC Criteria

October 23, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMT16049S

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ureteral Calculi

Clinical Trials on Control group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe