Clinical Study of Ningmitai Capsule on Promoting the Passage of Residual Fragments After Ureteroscopic Lithotripsy
NCT06105827 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 251
Last updated 2023-10-30
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.
Conditions
- Ureteral Calculi
Interventions
- 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.
Sponsors & Collaborators
-
Xintian Pharmaceutical
lead INDUSTRY
Principal Investigators
-
Yuan Jingdong, Doctor · Wuhan First Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-02
- Primary Completion
- 2019-04-25
- Completion
- 2019-04-25
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