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

Sponsor

Xintian Pharmaceutical (Industry)

Overall Status

Completed

CT.gov ID

NCT06105827

Collaborator

(none)

251

Enrollment

Arms

30.7

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ureteral Calculi	Drug: Control group Drug: Ningmitai capsule Drug: Combined group (Ningmitai plus tamsulosin)	Phase 4

Detailed Description

Sample size: 230

Study Design

Study Type:

Interventional

Actual Enrollment :

251 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 2, 2016

Actual Primary Completion Date :

Apr 25, 2019

Actual Study Completion Date :

Apr 25, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
Having ureteral residual fragments post URL and the diameter more than 5mm.
The lithotripsy went smoothly with expected outcomes and without any ureteral perforation, mucous exfoliation, kidney or bladder injury, serious bleeding or any other complications.
Willing and able to participate in this study and comply with all scheduled visits, treatment plans and complete the clinical observations.

Exclusion Criteria:

Pregnancy, severe diabetes, or renal insufficiency.
Ureteral stricture and lower urinary tract obstruction.
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.
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.
Severe adverse events and need to withdraw from the study.