A Phase 4 interventional study of Control group and Ningmitai capsule in Ureteral Calculi, sponsored by Xintian Pharmaceutical. Completed. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-10-30.
Sponsored by Xintian Pharmaceutical · Phase 4, Interventional, and Treatment
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.
Sample size: 230
50 studies on the registry are indexed under Ureteral Calculi; 14 are open to participants now.
This study's enrollment of 251 is above the median of 100 across 42 interventional studies indexed under Ureteral Calculi.
Browse Ureteral Calculi studies →Xintian Pharmaceutical is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Give antibiotics or diclofenac sodium suppository as needed.
Drug: Control group
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
Drug: Ningmitai capsule
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
Drug: Combined group (Ningmitai plus tamsulosin)
Give antibiotics or diclofenac sodium suppository as needed.
Also known as: diclofenac sodium
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.
Tamsulosin capsules, 0.2 mg/capsule, one capsule each time, once a day, were taken on the basis of Ningmitai group for 12 Weeks.
Also known as: Ningmitai plus tamsulosin
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.
Time frame: From baseline to 12 weeks of treatment
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.
Time frame: From baseline to 12 weeks of treatment
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Xintian Pharmaceutical