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Can an ancient herbal formula beat antibiotics for urinary infections?

NCT ID NCT07769060

Disease control Sponsor: Peking University First Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether a traditional Chinese medicine called Lishitonglin Formula can improve non-severe urinary tract infections and lower urinary tract symptoms in men with urethral stricture before they undergo surgery. Participants will take either the herbal formula or a placebo for one week prior to their operation. The study will compare bacterial clearance rates, symptom scores, and post-surgical outcomes to see if the formula is a safe and effective alternative to antibiotics.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lishitonglin Formula granules (a traditional Chinese medicine herbal formula)
What this could lead to
If effective, this herbal formula could offer an alternative to antibiotics for managing urinary tract infections in people with urethral stricture, potentially reducing the need for antibiotics before surgery.
What could go wrong
This is a small, early-stage trial, and the herbal formula may not prove more effective than placebo. As with any treatment, there is a risk of side effects or interactions with other medications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

urethral stricture urinary tract infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urethra stricture

Contacts and locations

Locations

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.