Uncomplicated urinary tract infections?Acute onset of recurrent urinary tract infections
Conditions
Interventions
Non-complicated urinary tract infection Experimental group:Yinhua Miyanling tablet (4 tablets, 4 times a day for 7 days) + levofloxacin tablet simulator (500 mg, 1 time a day for 3 days)
Non-complicated urinary tract infection Control group:Yinhua Miyanling tablet simulator (4 tablets, 4 times a day for 7 days) + levofloxacin tablet (500 mg, 1 time a day for 3 days)
rUTI Experimental group:Yinhua Miyanling tablet (4 tablets 4 times daily for 28 Days) + levofloxacin tablet simulator (500 mg, 1 time a day for 3 days)
rUTI Control group:Yinhua Miyanling tablet simulator (4 tablets, 4 times daily for 28 Days) + levofloxacin tablet (500 mg, 1 time a day for 3 days)
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18-65 (including 18 and 65 years old) with uncomplicated UTI and rUTI acute onset and diagnosed by Traditional Chinese medicine as lower scorched, damp and hot lymphoid; 2. Before the start of the trial, obtain the informed consent of the patient or his/her legal representative to sign the ethics committee; 3. Those who have symptoms of dysuria, urgency, frequency of urination, suprapogic pain and symptoms within 7 days before admission; 4. Urine routine examination shows that there is pyema, that is,: urine dipstick method leukocyte esterase is positive, or flow cytometry shows that urine leukocytes exceed the upper limit of normal value, or urinary sediment microscopy to detect leukocytes >5 / HP; 5. Clear consciousness, able to answer questions independently, and self-complete the assessment of the acute cystitis symptom scoring table (ACSS) according to the requirements of the test plan.
Exclusion criteria
Exclusion criteria: 1. Those who receive effective antibacterial drugs or proprietary Chinese medicines for urinary tract infections within 72 hours before enrollment for more than 24 hours; 2. Those who have a history of allergy to honeysuckle tablets and quinolones, or those who have had serious adverse reactions to quinolones in the past; 3. There are any complicated urinary tract infections or signs of pyelonephritis (manifested as low back pain, renal percussion, fever> 37.3 °C, constitutional symptoms); 4. Patients with the following underlying diseases: diabetes, severe insufficiency of renal function (creatinine clearance 100ml, vesicoureteral reflux or other abnormal function, urinary diversion, indwelling urinary catheter or stent tube or intermittent catheterization; 6. Other drugs with antibacterial and anti-inflammatory or urinary tract symptoms may be used during or before the end of the trial (including proprietary Chinese medicines, Chinese medicine tablets, antibacterial drugs, nonsteroidal anti-inflammatory drugs, a-blockers, M-receptor antagonists); 7. Pregnant or lactating or recently planned pregnancies and unwilling to use effective contraception; 8.Other investigators believe there may be conditions that increase the risk to subjects or interfere with clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients treated with additional antimicrobials for the treatment of UTIs between V0 (day 1) to V3 (days 38±3).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the acute cystitis symptom scoring scale (ACSS) score;Urinalysis;Urine bacterial culture;Proportion of patients with rUTI who were treated with additional antimicrobials for the treatment of urinary tract infections between V3 (day 38 ±3) to V4 (days 90±7).; | — |
Countries
China
Contacts
Public ContactChen Shan/Qiao Ludong:Gao Zhan
Beijing Tongren Hospital, Capital Medical University:Xiyuan Hospital of CACMS
Outcome results
None listed