NCT06105827

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Xintian Pharmaceutical · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Ureteral Calculi

Interventions

Type	Name	Description
DRUG	Control group	Give antibiotics or diclofenac sodium suppository as needed.
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.
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.

Timeline

• Start date: 2016-10-02
• Primary completion: 2019-04-25
• Completion: 2019-04-25
• First posted: 2023-10-30
• Last updated: 2023-10-30