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Evaluation of efficacy and safety of Ningmitai Capsule in excreting fragments after Retrograde Invasive Renal Surgery(RIRS)

Evaluation of efficacy and safety of Ningmitai Capsule in excreting fragments after Retrograde Invasive Renal Surgery(RIRS)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024151
Enrollment
Unknown
Registered
2019-06-28
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urolithiasis

Interventions

Experimental group:Ningmingtai
Control Group:Natural stone drainage method such as drinking more water moderate activities

Sponsors

The Second Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 60 years who had been diagnosed with upper urinary calculi,1.0-2.0 cm in size, by b-ultrasonography,KUB, IVP or non-enhanced computed tomography (CT). 2. All of them were completed by clinicians with more than 100 cases of experience and proficient in the operation of flexible ureteroscope lithotripsy. 3. Ureteroscopic lithotripsy was performed successfully without perforation of ureter, exfoliation of mucosa and injury of kidney and bladder. 4. Willing to participate in this study and actively cooperate with follow-up.

Exclusion criteria

Exclusion criteria: 1. Pregnancy, severe diabetes mellitus and renal insufficiency; 2. History of previous ipsilateral surgery or natural lithotripsy; 3. Patients with lower urinary tract obstruction; 4. Patients with incarcerated or infectious stones; 5. Preoperative reserved ureteral stent patients; 6. Taking alpha-1 receptor blockers and Chinese patent medicines which may affect the evaluation of the efficacy of lithotripsy within two weeks or allergic to experimental drugs; 7. Those who fail to use drugs according to the prescription can not judge the curative effect, or whose data are incomplete, which affects the judgement of effectiveness and safety; 8. Serious adverse events occur, and it is not appropriate to carry out the test again.

Design outcomes

Primary

MeasureTime frame
stone excretion rate;stone free rate;stone composition;

Secondary

MeasureTime frame
hematuria;pain;urinary tract infection;

Countries

China

Contacts

Public ContactChangbao Xu

The Second Affiliated Hospital of Zhengzhou University

251197998@qq.com+86 13653826598

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026