Ureteral CalculiPhase 43NCT06105827
Clinical Study of Ningmitai Capsule on Promoting the Passage of Residual Fragments After Ureteroscopic Lithotripsy
A Phase 4 study testing Ningmitai capsule and Combined group (Ningmitai plus tamsulosin) in people with Ureteral Calculi, run by Xintian Pharmaceutical.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Ureteral Calculi
- What is being tested?
- Ningmitai capsule and Combined group (Ningmitai plus tamsulosin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- No sites listed yet
- Study dates
- 2 Oct 2016to 25 Apr 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as upper urinary calculi by B-ultrasound, kidney and upper bladder (KUB), intravenous urogram (IVU) or computerized tomography (CT) before surgery with the ages between 20 and 70 years.
- Having ureteral residual fragments post URL and the diameter more than 5mm.
- The lithotripsy went smoothly with expected outcomes and without any ureteral perforation, mucous exfoliation, kidney or bladder injury, serious bleeding or any other complications.
- Willing and able to participate in this study and comply with all scheduled visits, treatment plans and complete the clinical observations.
Who cannot join
- Pregnancy, severe diabetes, or renal insufficiency.
- Ureteral stricture and lower urinary tract obstruction.
- Concomitant treatment with α1-receptor antagonists, or Chinese traditional medicines who can be used to relieve stranguria and expel stone, or any other treatment that might interference the efficacy evaluation.
- Unwilling or unable to comply with the administration regimen described in the protocol, or having an incomplete profile, hence their efficacy and safety couldn't be evaluated.
- Severe adverse events and need to withdraw from the study.
About this study
Official title: A Multicenter, Prospective, Randomized, Controlled Clinical Study of Ningmitai Capsule to Promote the Passage of Residual Fragments After Ureteroscopic Lithotripsy
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.
Read the detailed description
Sample size: 230
- Conditions
- Ureteral Calculi
- Being tested
- Control group, Ningmitai capsule, Combined group (Ningmitai plus tamsulosin)
- Keywords
- Ureteral calculi, Lithotripsy of ureteral calculi, Ningmitai capsule, Residual fragments
- Medical subject headings
- Ureteral Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupDrug
Also called diclofenac sodium
Give antibiotics or diclofenac sodium suppository as needed.
Ningmitai capsuleDrug
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)Drug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Give antibiotics or diclofenac sodium suppository as needed. Receives: Drug: Control group |
| Ningmitai capsule | Experimental | 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 Receives: Drug: Ningmitai capsule |
| Combined group (Ningmitai plus tamsulosin) | Experimental | 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 Receives: Drug: Combined group (Ningmitai plus tamsulosin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 12 weeks of treatment
Secondary outcomes (1)
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.
Measured: From baseline to 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start2 Oct 2016
- Primary completion25 Apr 2019
- Study completion25 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xintian Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuan Jingdong, Doctor, Principal investigator, Wuhan First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105827
- Sponsor's protocol ID
- NMT16049S
- Acronym
- 3
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Controlled Clinical Study of Ningmitai Capsule to Promote the Passage of Residual Fragments After Ureteroscopic Lithotripsy
- ClinicalTrials.gov ID
- NCT06105827
- Acronym / sponsor ID
- 3 / NMT16049S
- Conditions
- Ureteral Calculi
- Keywords
- Ureteral calculi, Lithotripsy of ureteral calculi, Ningmitai capsule, Residual fragments
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Xintian PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2016 (actual)
- Primary completion
- 25 Apr 2019 (actual)
- Study completion
- 25 Apr 2019 (actual)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Drug: Control groupGive antibiotics or diclofenac sodium suppository as needed. |
| Ningmitai capsule | Experimental | Drug: Ningmitai capsuleNingmitai 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 |
| Combined group (Ningmitai plus tamsulosin) | Experimental | 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. Course of treatment: 12 weeks |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed as upper urinary calculi by B-ultrasound, kidney and upper bladder (KUB), intravenous urogram (IVU) or computerized tomography (CT) before surgery with the ages between 20 and 70 years.
- Having ureteral residual fragments post URL and the diameter more than 5mm.
- The lithotripsy went smoothly with expected outcomes and without any ureteral perforation, mucous exfoliation, kidney or bladder injury, serious bleeding or any other complications.
- Willing and able to participate in this study and comply with all scheduled visits, treatment plans and complete the clinical observations.
Key exclusion criteria (5 listed)
- Pregnancy, severe diabetes, or renal insufficiency.
- Ureteral stricture and lower urinary tract obstruction.
- Concomitant treatment with α1-receptor antagonists, or Chinese traditional medicines who can be used to relieve stranguria and expel stone, or any other treatment that might interference the efficacy evaluation.
- Unwilling or unable to comply with the administration regimen described in the protocol, or having an incomplete profile, hence their efficacy and safety couldn't be evaluated.
- Severe adverse events and need to withdraw from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control groupAlso: diclofenac sodiumGive antibiotics or diclofenac sodium suppository as needed. | Drug | Control group |
| Ningmitai capsuleOral 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 | Ningmitai capsule |
| Combined group (Ningmitai plus tamsulosin)Also: Ningmitai plus tamsulosinTamsulosin capsules, 0.2 mg/capsule, one capsule each time, once a day, were taken on the basis of Ningmitai group for 12 Weeks. | Drug | Combined group (Ningmitai plus tamsulosin) |
Primary outcome
the stone expulsion time, stone-free time
Time frame: From baseline to 12 weeks of treatment
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.
1 secondary outcome
the stone expulsion rate and stone-free rate.
Time frame: From baseline to 12 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuan Jingdong, Doctor principal investigator
Wuhan First Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ningmitai capsule and Combined group (Ningmitai plus tamsulosin) in people with Ureteral Calculi, run by Xintian Pharmaceutical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the stone expulsion time, stone-free time (time frame: From baseline to 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.