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

Guiyang Xintian Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Ureteral Calculi

Treatments: Drug: Ningmitai capsule; Drug: Combined group (Ningmitai plus tamsulosin); Drug: Control group

Study type: Interventional

Funder types: Industry

Identifiers

NCT06105827

NMT16049S

Details and patient eligibility

About

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.

Full description

Sample size: 230

Enrollment: 251 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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251 participants in 3 patient groups

Control group

Other group

Description:

Give antibiotics or diclofenac sodium suppository as needed.

Treatment:

Drug: Control group

Ningmitai capsule

Experimental group

Description:

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

Treatment:

Drug: Ningmitai capsule

Combined group (Ningmitai plus tamsulosin)

Experimental group

Description:

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

Treatment:

Drug: Combined group (Ningmitai plus tamsulosin)