Recurrent urinary tract infections
Conditions
Interventions
High-dose group:Qichen Tonglin Tablets, 6 tablets per dose, 3 times daily, taken with warm water.
Low-dose group:Qichen Tonglin Tablets, 4 tablets per dose, 3 times daily + Qichen Tonglin Tablet placebo, 2 tablets per dose, 3 times daily, taken with warm water.
Placebo group:Qichen Tonglin simulator, 6 tablets per dose, 3 times daily, taken with warm water.
Sponsors
Guang'anmen Hospital of the Chinese Academy of Traditional Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Meets the clinical diagnostic criteria for acute lower urinary tract infection (presence of symptoms such as dysuria, urgency, and frequency, along with urine sediment microscopy showing white blood cells >5 per HP field is sufficient for inclusion); (2) Has experienced =2 episodes of urinary tract infection in the past 6 months, or =3 episodes in the past year (including the current acute infection); (3) Is diagnosed with Liver Meridian Qi Stagnation and Damp-Heat Accumulation in the Lower Jiao according to traditional Chinese medicine (TCM) differentiation; (4) Is a female aged between 18 and 70 years (inclusive); (5) Voluntarily agrees to participate in this clinical trial and signs a written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Combined upper urinary tract infections, urinary tuberculosis, gonorrhea, or other diseases that may affect the clinical efficacy evaluation; (2) Concurrent systemic infections or infections where the investigator deems that urinary tract infections require intravenous antibiotic treatment; (3) Combined severe urinary tract anatomical abnormalities, urinary tract obstruction caused by stones, bladder diverticula, urinary tract tumors, uremia, or post-organ transplant status; (4) History of urinary tract infections caused by mycoplasma, chlamydia, fungi, or parasites within the past year; (5) Use of more than 3 days of Chinese or Western medications for the treatment of urinary tract infections before enrollment following the onset of the current illness; (6) Combined severe cardiovascular, liver (ALT, AST, TBIL exceeding 1.5 times the upper limit of the normal range), kidney (Cr, BUN exceeding 1.5 times the upper limit of the normal range), respiratory, or hematological system diseases, malignant tumors, or mental disorders; (7) Type 1 diabetes or Type 2 diabetes with poor glycemic control (glycated hemoglobin >8.5%); (8) Allergy to antibiotics, making antibiotic treatment impossible, or allergy to components of the investigational drug; (9) Pregnant or breastfeeding women, or those planning pregnancy or unwilling to use effective contraceptive measures; (10) History of suspected or confirmed alcohol or substance abuse; (11) Participation in other drug clinical trials within the past 3 months prior to enrollment; (12) Other factors deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical recurrence rate/average recurrence frequency during the entire study period (treatment period + follow-up period);Throughout the entire study period (treatment and follow-up periods), the recurrence rate of positive urine bacteriology/average recurrence frequency.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical recurrence rate / Average recurrence frequency during treatment period;The recurrence rate/average recurrence frequency of positive urine bacteriology during the treatment period.;Clinical recurrence rate/average recurrence frequency during the follow-up period.;Follow-up period positive urine bacteriology recurrence rate/average recurrence frequency;Time of first Urinary Tract Infection recurrence;Time to first recurrence of urinary tract infection after clinical response;Clinical Response, Microbial Response, and Overall Efficacy in Acute Lower Urinary Tract Infection.;Time to resolution of acute infection clinical symptoms;Duration of antibiotic use (treatment period + follow-up period);Total TCM syndrome score and individual symptom scores compared to baseline changes.;Evaluation of therapeutic effects on TCM syndromes; | — |
Countries
China
Contacts
Public ContactZhan Yongli
Guang'anmen Hospital of the Chinese Academy of Traditional Medicine
Outcome results
None listed