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LishitonglinUS-01 Trial
Sponsor: Peking University First Hospital
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 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.
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
Key Details
Gender
MALE
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-01-09
Completion Date
2028-08-31
Last Updated
2026-08-17
Healthy Volunteers
No
Conditions
Interventions
Lishitonglin Formula granules
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 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).
Locations (1)
Peking University First Hospital
Beijing, Beijing Municipality, China