A Phase 2 interventional study of Lishitonglin Formula granules and Oral placebo medication formulated as granules in Urethra Stricture, sponsored by Peking University First Hospital. Active, not recruiting at 1 site in China. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Peking University First Hospital · Phase 2, Interventional, and Treatment
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.
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.
72 studies on the registry are indexed under Urethral Stricture; 25 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 56 interventional studies indexed under Urethral Stricture.
Browse Urethral Stricture studies →Peking University First Hospital is the lead sponsor of 390 studies on the registry; 186 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Begin taking the oral Lishitonglin Formula granules one week prior to surgery (one dose twice daily, dissolved in warm water).
Drug: Lishitonglin Formula granules
Begin taking the oral Lishitonglin Formula granules one week prior to surgery (one dose twice daily, dissolved in warm water).
Drug: Lishitonglin Formula granules
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).
Drug: Oral placebo medication formulated as granules
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).
Drug: Oral placebo medication formulated as granules
Begin taking the oral Lishitonglin Formula granules one week prior to surgery (one dose twice daily, dissolved in warm water).
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).
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
Time frame: Before taking the drug and one day before operation
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)
Time frame: 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)
Time frame: Before taking the drug and one day before operation
Recurrence rate
US Recurrence rate, followed by Urethrography, uroflowmetry, urethroscopy, and IPSS score
Time frame: Postoperative 3 months & 1 year
Drug related adverse effects
Drug related adverse effects detected by real-time observation, inquiry, and recording
Time frame: 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.
Time frame: 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.
Time frame: Before taking the drug and one day before operation
Plan to share: Undecided — The original data of this trial could be obtained after applying to and receiving approval from the researcher
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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