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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06105827
Other study ID # NMT16049S
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 2, 2016
Est. completion date April 25, 2019

Study information

Verified date October 2023
Source Xintian Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Sample size: 230


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Control group
Give antibiotics or diclofenac sodium suppository as needed.
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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Xintian Pharmaceutical

Outcome

Type Measure Description Time frame Safety issue
Primary the stone expulsion time, stone-free time 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 the stone expulsion rate and stone-free rate. 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
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