Urethra StricturePhase 2NCT07769060
LishitonglinUS-01 Trial
A Phase 2 study testing Lishitonglin Formula granules in people with Urethra Stricture, run by Peking University First Hospital at 1 site in China.
Trial summary
This study intends to conduct a prospective, randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of Lishi Tonglin Granule (a hospital-formulated innovative prescription) developed in our hospital for alleviating preoperative urinary tract infections in patients with urethral… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Urethra Stricture
- What is being tested?
- Lishitonglin Formula granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2026to 31 Aug 2028
- Phase
- Phase 2
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Adult male patients (≥18 years old) with urethral stricture diagnosed by urethrography and presenting urinary obstruction symptoms (AUA grade II-III) with or without preoperative bladder diversion via ostomy.
- 2. No concurrent severe urinary tract infection (meeting both criteria): · Urinary tract irritation symptoms (frequency, urgency, dysuria)
- 3. Urinary leukocytes ≥10 (HPF)
- 4. Midstream urine culture colony count ≥10⁵ CFU/mL
- 5. Traditional Chinese Medicine pattern identification: damp-heat descending syndrome (primary symptoms: frequent, urgent, painful urination, red tongue with thick yellow coating)
- 6. Planned intraurethral procedures (including urethrotomy/urethral dilation/urethral balloon dilation) or open urethroplasty (including end-to-end urethral stricture resection/autologous mucosal patch urethroplasty).
Who cannot join
- 1. Patients with severe infection presenting clinically significant symptoms at enrollment: e.g., those with fever, active hematuria, pyuria, urethral condyloma, or septic shock
- 2. Urinary tract infections complicated by complex urinary tract anomalies (e.g., congenital hypospadias, fistula) or uncontrolled malignant tumors such as urethral cancer or bladder cancer
- 3. Severe hepatic or renal dysfunction (ALT/AST > 2× upper limit of normal, Scr > 133 μmol/L)
- 4. Concurrent immunodeficiency disorders or use of immunosuppressive agents
- 5. Allergy to any component of the study drug
- 6. Individuals refusing to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: Efficacy and Safety Evaluation of Lishitonglin Formula in Improving Preoperative Non-Severe Urinary Tract Infections and Lower Urinary Tract Symptoms in Patients With Urethral Stricture
This study intends to conduct a prospective, randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of Lishi Tonglin Granule (a hospital-formulated innovative prescription) developed in our hospital for alleviating preoperative urinary tract infections in patients with urethral stricture, and to further explore its effects on preoperative lower urinary tract irritation symptoms as well as short- and medium-term postoperative stricture recurrence rates.
This protocol is jointly implemented by the Department of Urology and the Department of Integrated Traditional Chinese and Western Medicine. Adopting the TCM therapeutic concept of "clearing the source and unblocking collaterals" combined with Western surgical intervention, the trial compares the primary outcome measures between the intervention group (administered Lishi Tonglin Prescription) and the control group (administered placebo), including preoperative bacteriuria clearance rate, lower urinary tract symptom scores and TCM syndrome scores, to identify significant intergroup differences.
Comprehensive analyses will also be performed on postoperative short- and medium-term urination improvement, urethral stricture recurrence risk, distribution of uropathogens and antimicrobial susceptibility profiles of the two groups. This research features innovations in integrated Chinese-Western diagnostic and therapeutic theories, prescription optimization, and a multi-dimensional evaluation framework. Its findings can validate the clinical potential of Lishi Tonglin Prescription as an alternative to antibiotics, and lay a theoretical foundation for future mechanistic research and clinical translation of integrated Chinese-Western therapy for urinary tract infections secondary to lower urinary tract obstruction.
Read the detailed description
This study intends to conduct a prospective, randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of Lishi Tonglin Granule (a hospital-formulated innovative prescription) developed in our hospital for alleviating preoperative urinary tract infections in patients with urethral stricture, and to further explore its effects on preoperative lower urinary tract irritation symptoms as well as short- and medium-term postoperative stricture recurrence rates.
This protocol is jointly implemented by the Department of Urology and the Department of Integrated Traditional Chinese and Western Medicine. Adopting the TCM therapeutic concept of "clearing the source and unblocking collaterals" combined with Western surgical intervention, the trial compares the primary outcome measures between the intervention group (administered Lishi Tonglin Prescription) and the control group (administered placebo), including preoperative bacteriuria clearance rate, lower urinary tract symptom scores and TCM syndrome scores, to identify significant intergroup differences.
Comprehensive analyses will also be performed on postoperative short- and medium-term urination improvement, urethral stricture recurrence risk, distribution of uropathogens and antimicrobial susceptibility profiles of the two groups. This research features innovations in integrated Chinese-Western diagnostic and therapeutic theories, prescription optimization, and a multi-dimensional evaluation framework. Its findings can validate the clinical potential of Lishi Tonglin Prescription as an alternative to antibiotics, and lay a theoretical foundation for future mechanistic research and clinical translation of integrated Chinese-Western therapy for urinary tract infections secondary to lower urinary tract obstruction.
- Conditions
- Urethra Stricture
- Being tested
- Lishitonglin Formula granules, Oral placebo medication formulated as granules
- Keywords
- Urethra stricture, Lishitonglin Formula, Perioperational urinary infection, RCT
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lishitonglin Formula granulesDrug
Begin taking the oral Lishitonglin Formula granules one week prior to surgery (one dose twice daily, dissolved in warm water).
Oral placebo medication formulated as granulesDrug
One week prior to surgery, patients began receiving oral placebo medication formulated as granules containing 10% of the active ingredients and matching the appearance of the LIshitonglin formula (1 dose twice daily, dissolved in warm water).
| Study group | Role | What they receive |
|---|---|---|
| Trial Group - Mild Stenosis Group | Experimental | Begin taking the oral Lishitonglin Formula granules one week prior to surgery (one dose twice daily, dissolved in warm water). Receives: Drug: Lishitonglin Formula granules |
| Trial Group - Moderate to Severe Stenosis Group | Experimental | Begin taking the oral Lishitonglin Formula granules one week prior to surgery (one dose twice daily, dissolved in warm water). Receives: Drug: Lishitonglin Formula granules |
| Control Group - Mild Stenosis Group | Placebo comparator | One week prior to surgery, patients began receiving oral placebo medication formulated as granules containing 10% of the active ingredients and matching the appearance of the LIshitonglin formula (1 dose twice daily, dissolved in warm water). Receives: Drug: Oral placebo medication formulated as granules |
| Control Group - Moderate to Severe Stenosis Group | Placebo comparator | One week prior to surgery, patients began receiving oral placebo medication formulated as granules containing 10% of the active ingredients and matching the appearance of the LIshitonglin formula (1 dose twice daily, dissolved in warm water). Receives: Drug: Oral placebo medication formulated as granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial clearance rate
After 7 days of treatment, the rate of reduction in urinary leukocyte count under high-power microscopy compared to pre-treatment levels, urinary leukocyte count (high-power microscopy), and urinary culture conversion rate
Measured: Before taking the drug and one day before operation
Secondary outcomes (6)
Urine White Blood Cell Count on the First Day After Surgery
Urine White Blood Cell Count Under High-Power Microscope in a Routine Urinalysis (Unit: cells/HP)
Measured: Postoperative Day 1
Traditional Chinese Medicine Syndrome Scoring
Urinating stenosis, frequent urination, urgency, and painful urination (4 items; scored on a 0-3 scale, with each item scored separately; 0 being the mildest and 3 the most severe)
Measured: Before taking the drug and one day before operation
Recurrence rate
US Recurrence rate, followed by Urethrography, uroflowmetry, urethroscopy, and IPSS score
Measured: Postoperative 3 months & 1 year
Drug related adverse effects
Drug related adverse effects detected by real-time observation, inquiry, and recording
Measured: Through study completion, on average of 1 week
Urine Culture Positivity Rates and Microorganism Types
This refers to the proportion of patients with positive preoperative urine cultures, and includes documentation of the microbial species and antibiotic resistance profiles of the positive cultures.
Measured: Before taking the drug and one day before operation
International Prostate Symptom Score (IPSS)
This scale includes seven symptoms: frequent urination, urinary urgency, nocturia, incomplete emptying, interrupted urination, difficulty urinating, and a weak urine stream. Each symptom is scored on a scale of 0-5 based on frequency and severity. The total score is categorized as follows: (0-7) mild, (8-19) moderate, and (20-35) severe.
Measured: Before taking the drug and one day before operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start9 Jan 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Urethra StrictureStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, double-blind, control study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunru Xu, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769060
- Sponsor's protocol ID
- BJZYQN-2025-04
- Other IDs
- BJZYQN-2025-04
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The original data of this trial could be obtained after applying to and receiving approval from the researcher
Publications
Kim S, Cheng KC, Alsikafi NF, Breyer BN, Broghammer JA, Elliott SP, Erickson BA, Myers JB, Smith TG 3rd, Vanni AJ, Voelzke BB, Zhao LC, Buckley JC. Minimizing Antibiotic Use in Urethral Reconstruction. J Urol. 2022 Jul;208(1):128-134. doi: 10.1097/JU.0000000000002487. Epub 2022 Feb 25.
PubMed 35212569Heyns CF. Urinary tract infection associated with conditions causing urinary tract obstruction and stasis, excluding urolithiasis and neuropathic bladder. World J Urol. 2012 Feb;30(1):77-83. doi: 10.1007/s00345-011-0725-9. Epub 2011 Jul 1.
PubMed 21720861Shaw NM, Venkatesan K. Endoscopic Management of Urethral Stricture: Review and Practice Algorithm for Management of Male Urethral Stricture Disease. Curr Urol Rep. 2018 Feb 26;19(3):19. doi: 10.1007/s11934-018-0771-6.
PubMed 29479640Hampson LA, McAninch JW, Breyer BN. Male urethral strictures and their management. Nat Rev Urol. 2014 Jan;11(1):43-50. doi: 10.1038/nrurol.2013.275. Epub 2013 Dec 17.
PubMed 24346008Campos-Juanatey F, Osman NI, Greenwell T, Martins FE, Riechardt S, Waterloos M, Barratt R, Chan G, Esperto F, Ploumidis A, Verla W, Dimitropoulos K, Lumen N. European Association of Urology Guidelines on Urethral Stricture Disease (Part 2): Diagnosis, Perioperative Management, and Follow-up in Males. Eur Urol. 2021 Aug;80(2):201-212. doi: 10.1016/j.eururo.2021.05.032. Epub 2021 Jun 5.
PubMed 34103180Payne SR, Anderson P, Spasojevic N, Demilow TL, Teferi G, Dickerson D. Male urethral stricture disease: why management guidelines are challenging in low-income countries. BJU Int. 2022 Aug;130(2):157-165. doi: 10.1111/bju.15831. Epub 2022 Jul 7.
PubMed 35726391
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Lishitonglin Formula in Improving Preoperative Non-Severe Urinary Tract Infections and Lower Urinary Tract Symptoms in Patients With Urethral Stricture
- ClinicalTrials.gov ID
- NCT07769060
- Acronym / sponsor ID
- BJZYQN-2025-04
- Conditions
- Urethra Stricture
- Keywords
- Urethra stricture, Lishitonglin Formula, Perioperational urinary infection, RCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 17 Aug 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.
This study intends to conduct a prospective, randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of Lishi Tonglin Granule (a hospital-formulated innovative prescription) developed in our hospital for alleviating preoperative urinary tract infections in patients with urethral stricture, and to further explore its effects on preoperative lower urinary tract irritation symptoms as well as short- and medium-term postoperative stricture recurrence rates.
This protocol is jointly implemented by the Department of Urology and the Department of Integrated Traditional Chinese and Western Medicine. Adopting the TCM therapeutic concept of "clearing the source and unblocking collaterals" combined with Western surgical intervention, the trial compares the primary outcome measures between the intervention group (administered Lishi Tonglin Prescription) and the control group (administered placebo), including preoperative bacteriuria clearance rate, lower urinary tract symptom scores and TCM syndrome scores, to identify significant intergroup differences.
Comprehensive analyses will also be performed on postoperative short- and medium-term urination improvement, urethral stricture recurrence risk, distribution of uropathogens and antimicrobial susceptibility profiles of the two groups. This research features innovations in integrated Chinese-Western diagnostic and therapeutic theories, prescription optimization, and a multi-dimensional evaluation framework. Its findings can validate the clinical potential of Lishi Tonglin Prescription as an alternative to antibiotics, and lay a theoretical foundation for future mechanistic research and clinical translation of integrated Chinese-Western therapy for urinary tract infections secondary to lower urinary tract obstruction.
Detailed description
This study intends to conduct a prospective, randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of Lishi Tonglin Granule (a hospital-formulated innovative prescription) developed in our hospital for alleviating preoperative urinary tract infections in patients with urethral stricture, and to further explore its effects on preoperative lower urinary tract irritation symptoms as well as short- and medium-term postoperative stricture recurrence rates.
This protocol is jointly implemented by the Department of Urology and the Department of Integrated Traditional Chinese and Western Medicine. Adopting the TCM therapeutic concept of "clearing the source and unblocking collaterals" combined with Western surgical intervention, the trial compares the primary outcome measures between the intervention group (administered Lishi Tonglin Prescription) and the control group (administered placebo), including preoperative bacteriuria clearance rate, lower urinary tract symptom scores and TCM syndrome scores, to identify significant intergroup differences.
Comprehensive analyses will also be performed on postoperative short- and medium-term urination improvement, urethral stricture recurrence risk, distribution of uropathogens and antimicrobial susceptibility profiles of the two groups. This research features innovations in integrated Chinese-Western diagnostic and therapeutic theories, prescription optimization, and a multi-dimensional evaluation framework. Its findings can validate the clinical potential of Lishi Tonglin Prescription as an alternative to antibiotics, and lay a theoretical foundation for future mechanistic research and clinical translation of integrated Chinese-Western therapy for urinary tract infections secondary to lower urinary tract obstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- Prospective, randomized, double-blind, control study
| Arm | Type | Receives |
|---|---|---|
| Trial Group - Mild Stenosis Group | Experimental | Drug: Lishitonglin Formula granulesBegin taking the oral Lishitonglin Formula granules one week prior to surgery (one dose twice daily, dissolved in warm water). |
| Trial Group - Moderate to Severe Stenosis Group | Experimental | Drug: Lishitonglin Formula granulesBegin taking the oral Lishitonglin Formula granules one week prior to surgery (one dose twice daily, dissolved in warm water). |
| Control Group - Mild Stenosis Group | Placebo comparator | Drug: Oral placebo medication formulated as granulesOne week prior to surgery, patients began receiving oral placebo medication formulated as granules containing 10% of the active ingredients and matching the appearance of the LIshitonglin formula (1 dose twice daily, dissolved in warm water). |
| Control Group - Moderate to Severe Stenosis Group | Placebo comparator | Drug: Oral placebo medication formulated as granulesOne week prior to surgery, patients began receiving oral placebo medication formulated as granules containing 10% of the active ingredients and matching the appearance of the LIshitonglin formula (1 dose twice daily, dissolved in warm water). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Adult male patients (≥18 years old) with urethral stricture diagnosed by urethrography and presenting urinary obstruction symptoms (AUA grade II-III) with or without preoperative bladder diversion via ostomy.
- 2. No concurrent severe urinary tract infection (meeting both criteria): · Urinary tract irritation symptoms (frequency, urgency, dysuria)
- 3. Urinary leukocytes ≥10 (HPF)
- 4. Midstream urine culture colony count ≥10⁵ CFU/mL
- 5. Traditional Chinese Medicine pattern identification: damp-heat descending syndrome (primary symptoms: frequent, urgent, painful urination, red tongue with thick yellow coating)
Key exclusion criteria (6 listed)
- 1. Patients with severe infection presenting clinically significant symptoms at enrollment: e.g., those with fever, active hematuria, pyuria, urethral condyloma, or septic shock
- 2. Urinary tract infections complicated by complex urinary tract anomalies (e.g., congenital hypospadias, fistula) or uncontrolled malignant tumors such as urethral cancer or bladder cancer
- 3. Severe hepatic or renal dysfunction (ALT/AST > 2× upper limit of normal, Scr > 133 μmol/L)
- 4. Concurrent immunodeficiency disorders or use of immunosuppressive agents
- 5. Allergy to any component of the study drug
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 |
|---|---|---|
| Lishitonglin Formula granulesBegin taking the oral Lishitonglin Formula granules one week prior to surgery (one dose twice daily, dissolved in warm water). | Drug | Trial Group - Mild Stenosis Group, Trial Group - Moderate to Severe Stenosis Group |
| Oral placebo medication formulated as granulesOne week prior to surgery, patients began receiving oral placebo medication formulated as granules containing 10% of the active ingredients and matching the appearance of the LIshitonglin formula (1 dose twice daily, dissolved in warm water). | Drug | Control Group - Mild Stenosis Group, Control Group - Moderate to Severe Stenosis Group |
Primary outcome
Bacterial clearance rate
Time frame: Before taking the drug and one day before operation
After 7 days of treatment, the rate of reduction in urinary leukocyte count under high-power microscopy compared to pre-treatment levels, urinary leukocyte count (high-power microscopy), and urinary culture conversion rate
6 secondary outcomes
Urine White Blood Cell Count on the First Day After Surgery
Time frame: Postoperative Day 1
Traditional Chinese Medicine Syndrome Scoring
Time frame: Before taking the drug and one day before operation
Recurrence rate
Time frame: Postoperative 3 months & 1 year
Drug related adverse effects
Time frame: Through study completion, on average of 1 week
Urine Culture Positivity Rates and Microorganism Types
Time frame: Before taking the drug and one day before operation
International Prostate Symptom Score (IPSS)
Time frame: Before taking the drug and one day before operation
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 17 Aug 2026.
- Background: PubMed 35212569Kim S, Cheng KC, Alsikafi NF, Breyer BN, Broghammer JA, Elliott SP, Erickson BA, Myers JB, Smith TG 3rd, Vanni AJ, Voelzke BB, Zhao LC, Buckley JC. Minimizing Antibiotic Use in Urethral Reconstruction. J Urol. 2022 Jul;208(1):128-134. doi: 10.1097/JU.0000000000002487. Epub 2022 Feb 25.
- Background: PubMed 21720861Heyns CF. Urinary tract infection associated with conditions causing urinary tract obstruction and stasis, excluding urolithiasis and neuropathic bladder. World J Urol. 2012 Feb;30(1):77-83. doi: 10.1007/s00345-011-0725-9. Epub 2011 Jul 1.
- Background: PubMed 29479640Shaw NM, Venkatesan K. Endoscopic Management of Urethral Stricture: Review and Practice Algorithm for Management of Male Urethral Stricture Disease. Curr Urol Rep. 2018 Feb 26;19(3):19. doi: 10.1007/s11934-018-0771-6.
- Background: PubMed 24346008Hampson LA, McAninch JW, Breyer BN. Male urethral strictures and their management. Nat Rev Urol. 2014 Jan;11(1):43-50. doi: 10.1038/nrurol.2013.275. Epub 2013 Dec 17.
- Background: PubMed 34103180Campos-Juanatey F, Osman NI, Greenwell T, Martins FE, Riechardt S, Waterloos M, Barratt R, Chan G, Esperto F, Ploumidis A, Verla W, Dimitropoulos K, Lumen N. European Association of Urology Guidelines on Urethral Stricture Disease (Part 2): Diagnosis, Perioperative Management, and Follow-up in Males. Eur Urol. 2021 Aug;80(2):201-212. doi: 10.1016/j.eururo.2021.05.032. Epub 2021 Jun 5.
- Background: PubMed 35726391Payne SR, Anderson P, Spasojevic N, Demilow TL, Teferi G, Dickerson D. Male urethral stricture disease: why management guidelines are challenging in low-income countries. BJU Int. 2022 Aug;130(2):157-165. doi: 10.1111/bju.15831. Epub 2022 Jul 7.
- Individual participant dataSharing planned: Undecided. The original data of this trial could be obtained after applying to and receiving approval from the researcher
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lishitonglin Formula granules in people with Urethra Stricture, run by Peking University First Hospital at 1 site in China.
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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Bacterial clearance rate (time frame: Before taking the drug and one day before operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07769060, which also lists 6 linked publications.
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 17 Aug 2026.