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

Phase 4

Completed

• Conditions: Ureteral Calculi
• Interventions: Drug: Control group; Drug: Combined group (Ningmitai plus tamsulosin); Drug: Ningmitai capsule

• Registration Number: NCT06105827
• Lead Sponsor: Xintian Pharmaceutical

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

Study Timeline

• Study Start: 2016-10-02
• Primary Completion: 2019-04-25
• Study Completion: 2019-04-25
• Status Verified: 2023-10
• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-23
• Last Update Submitted: 2023-10-23
• Study First Posted: 2023-10-30
• Last Update Posted: 2023-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	Give antibiotics or diclofenac sodium suppository as needed.
Combined group (Ningmitai plus tamsulosin)	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
Ningmitai capsule	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.