Calculus of Upper Urinary TractPhase 4NCT07914686
A Study on the Efficacy and Safety of Ningmitai Capsules in Treating Patients With Upper Urinary Tract Stones After Extracorporeal Shock Wave Lithotripsy
A Phase 4 study testing Ningmitai Capsule in people with Calculus of Upper Urinary Tract, run by Xintian Pharmaceutical.
Trial summary
The goal of this clinical trial is to learn if Ningmitai capsules works to treat patients with upper urinary tract calculi after extracorporeal shock wave lithotripsy in adults. It will also learn about the safety of Ningmitai capsules. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Calculus of Upper Urinary Tract
- What is being tested?
- Ningmitai Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 31 Oct 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 70 years (inclusive of the threshold value);
- Suffering from a single non-transparent X-ray kidney stone or ureteral stone, which was confirmed through abdominal CT scan before the operation, with the longest diameter ranging from 6 to 20 mm, and the CT value being less than 1000 HU;
- Evaluated to be planned for single extracorporeal shock wave lithotripsy (ESWL) treatment, and confirmed by KUB X-ray examination 3 ± 1 days after ESWL that the maximum residual stone length in the upper urinary tract is greater than 2 mm and less than or equal to 7 mm;
- Voluntary participant and signed the informed consent form.
Who cannot join
- Patients with the target stones located in the lower calyx of the kidney, the bladder or the urethra;
- Patients with stone entrapment, infectious stones or antler-shaped stones;
- Patients confirmed to have stones by imaging examination;
- Patients who, based on the investigator's judgment, are expected to require secondary ESWL treatment due to residual stones during the study period, or will undergo surgical treatments such as physical vibration lithotripsy, ureteroscopy lithotripsy, percutaneous nephroscope lithotripsy, laparoscopic or open surgery lithotripsy, etc. during the study period;
- Patients who have undergone ESWL, physical vibration lithotripsy, ureteroscopy lithotripsy, percutaneous nephroscope lithotripsy, laparoscopic or open surgery lithotripsy, etc. for ureter or kidney surgery within the past 3 months;
- Patients with indwelling ureteral stents;
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- Patients with abnormal urinary tract anatomical structures that affect stone expulsion, such as known or suspected ureteropelvic junction obstruction, ureteral stenosis, urinary tract malformations, or previous history of urinary tract reconstruction surgery, scar adhesion, etc.;
- Patients with bladder outlet obstruction or neurogenic bladder;
- Patients with abnormal renal collecting system anatomy, such as isolated kidney, horseshoe kidney, ectopic kidney, transplanted kidney, etc.;
- Patients with severe (grade III) hydronephrosis or a clinically significant renal cyst on the affected side, such as renal parenchymal cysts compressing the renal collecting system, or renal cysts with a risk of rupture or bleeding as determined by the investigator during ESWL;
- Patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of the reference range (ULN), or serum creatinine (Scr) > 1.5×ULN, or renal insufficiency on the affected side;
- Patients with severe obesity (BMI > 37.5 kg/m2) or patients with severe skeletal deformities that are judged by the investigator to affect stone localization;
- Patients with poorly controlled diabetes (fasting blood glucose > 10.0 mmol/L or glycosylated hemoglobin > 8.0%) or hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg) or uncorrected coagulation dysfunction;
- Patients with untreated urinary tract infections, or those with fever or clear laboratory infection evidence at the time of screening, defined as: body temperature ≥ 38.0°C, or white blood cell count > 10×10⁹/L;
- Patients with renal aneurysm and/or abdominal aortic aneurysm;
- Patients with other severe systemic diseases and functional impairments, as determined by the investigator to be unsuitable for inclusion, including but not limited to respiratory system diseases, circulatory system diseases, endocrine system diseases, digestive system diseases, urinary system diseases, immune-related diseases and hematological diseases, severe neurological or mental diseases, etc.;
- Patients who used study-contraindicated concomitant drugs within 1 week before randomization (α receptor blockers, calcium channel blockers, PDE5 inhibitors, progesterone, hydrochlorothiazide tablets, thiazide diuretics, basic citrate, allopurinol, febuxostat, acetohydroxamic acid capsules, except for the investigational drugs, other drugs with therapeutic effects on urinary stones or with diuretic, litholytic, stone expulsion-related functions) or other drugs with urinary system stone-lowering effects (except for emergency spasm-relieving, anti-inflammatory, analgesic medications);
- Patients known to be allergic or intolerant to the investigational drug or its components;
- Pregnant or lactating women, or those with a fertility plan within the past 3 months;
- Patients suspected or confirmed to have a history of alcohol or drug abuse;
- Patients who have participated in other clinical trials of drugs or medical devices within the past month;
- Patients considered not suitable for inclusion by the investigator.
About this study
Official title: Study on the Efficacy and Safety of Ningmitai Capsules in Treating Patients With Upper Urinary Tract Calculi After Extracorporeal Shock Wave Lithotripsy: A Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Trial
The goal of this clinical trial is to learn if Ningmitai capsules works to treat patients with upper urinary tract calculi after extracorporeal shock wave lithotripsy in adults. It will also learn about the safety of Ningmitai capsules.
- Conditions
- Calculus of Upper Urinary Tract
- Being tested
- Ningmitai Capsule, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ningmitai CapsuleDrug
The ingredients include Forsythia suspensa, Imperata cylindrica, Lonicerae japonica, Tripterygium wilfordii, Anemone lanata, Hibiscus mutabilis, and Forsythia suspensa.
placeboDrug
Ningmitai Simulant
| Study group | Role | What they receive |
|---|---|---|
| Ningmitai Capsule | Experimental | Take orally, 4 capsules each time, 3 times a day. Receives: Drug: Ningmitai Capsule |
| placebo | Placebo comparator | It is similar to Ningmitai Capsules in terms of color, odor, taste, shape, texture and other characteristics. Take orally, 4 capsules each time, 3 times a day. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-free rate
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calculus of Upper Urinary TractStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xintian Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914686
- Sponsor's protocol ID
- NM-26-A-002-YJ-002
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 4 Nov 2026
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Safety of Ningmitai Capsules in Treating Patients With Upper Urinary Tract Calculi After Extracorporeal Shock Wave Lithotripsy: A Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Trial
- ClinicalTrials.gov ID
- NCT07914686
- Acronym / sponsor ID
- NM-26-A-002-YJ-002
- Conditions
- Calculus of Upper Urinary Tract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xintian PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 4 Nov 2026 (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.
The goal of this clinical trial is to learn if Ningmitai capsules works to treat patients with upper urinary tract calculi after extracorporeal shock wave lithotripsy in adults. It will also learn about the safety of Ningmitai capsules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ningmitai Capsule | Experimental | Drug: Ningmitai CapsuleTake orally, 4 capsules each time, 3 times a day. |
| placebo | Placebo comparator | Drug: placeboIt is similar to Ningmitai Capsules in terms of color, odor, taste, shape, texture and other characteristics. Take orally, 4 capsules each time, 3 times a day. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 - 70 years (inclusive of the threshold value);
- Suffering from a single non-transparent X-ray kidney stone or ureteral stone, which was confirmed through abdominal CT scan before the operation, with the longest diameter ranging from 6 to 20 mm, and the CT value being less than 1000 HU;
- Evaluated to be planned for single extracorporeal shock wave lithotripsy (ESWL) treatment, and confirmed by KUB X-ray examination 3 ± 1 days after ESWL that the maximum residual stone length in the upper urinary tract is greater than 2 mm and less than or equal to 7 mm;
- Voluntary participant and signed the informed consent form.
Key exclusion criteria (22 listed)
- Patients with the target stones located in the lower calyx of the kidney, the bladder or the urethra;
- Patients with stone entrapment, infectious stones or antler-shaped stones;
- Patients confirmed to have stones by imaging examination;
- Patients who, based on the investigator's judgment, are expected to require secondary ESWL treatment due to residual stones during the study period, or will undergo surgical treatments such as physical vibration lithotripsy, ureteroscopy lithotripsy, percutaneous nephroscope lithotripsy, laparoscopic or open surgery lithotripsy, etc. during the study period;
- Patients who have undergone ESWL, physical vibration lithotripsy, ureteroscopy lithotripsy, percutaneous nephroscope lithotripsy, laparoscopic or open surgery lithotripsy, etc. for ureter or kidney surgery within the past 3 months;
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 |
|---|---|---|
| Ningmitai CapsuleThe ingredients include Forsythia suspensa, Imperata cylindrica, Lonicerae japonica, Tripterygium wilfordii, Anemone lanata, Hibiscus mutabilis, and Forsythia suspensa. | Drug | Ningmitai Capsule |
| placeboNingmitai Simulant | Drug | placebo |
Primary outcome
Stone-free rate
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ningmitai Capsule in people with Calculus of Upper Urinary Tract, 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 22 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: opening soon, as of the sponsor's last update on 4 Nov 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Stone-free rate (time frame: 4 weeks). 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 4 Nov 2026.