Urinary Tract Infections
Conditions
Interventions
Control group:Relinqing Keli,Hugan buzure Keli placebo
Experimental group:Hugan buzure Keli,Relinqing Keli placebo
Sponsors
Shuguang hospital affiliated to Shanghai University of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1)Age between 18 and 65 years old; (2)Meet the diagnostic criteria for acute exacerbation of recurrent urinary tract infection with a clinical symptom score of any single symptom > 2 points; (3)Traditional Chinese medicine (TCM) differentiation conforms to pattern of dampness and heat in the lower energizer; (4)Voluntary signing of the informed consent form to participate in the trial.
Exclusion criteria
Exclusion criteria: (1)Individuals with severe primary diseases of the cardiovascular liver kidney brain endocrine or hematopoietic systems; (2)Patients with perinephric abscess renal papillary necrosis obstruction tuberculosis or stones in the urinary system; (3)Presence of systemic infection signs such as white blood cell count exceeding the upper limit of normal body temperature > 38°C chills etc.; (4)ALT levels more than twice the upper limit of normal; (5)Estimated glomerular filtration rate (eGFR) calculated using the EPI simplified formula < 30 mL/min/1.73m²; (6)Patients with diabetes; (7)Patients with various complex factors that easily induce recurrent urinary tract infections including urinary calculi urethral stenosis anatomical abnormalities or urinary functional abnormalities such as neurogenic bladder; (8)Urinary sediment microscopy showing leukocyte casts or signs of impaired renal tubular function suggesting upper urinary tract infection; (9)Patients with symptoms of gonorrhea genital ulcers or vaginitis; (10)Patients who have received effective antibiotic treatment for their recurrent urinary tract infection within 48 hours before randomization; (11)Female patients during menstruation; (12)Patients allergic to the investigational drug or its components; (13)Patients who have participated in other clinical trials within 3 months prior to this study; (14)Pregnant breastfeeding or planning to conceive or breastfeed during the study period or fertile women not using effective contraception; (15)Patients with mental illness suspected or confirmed history of alcohol or drug abuse; (16)Patients whom the investigator deems unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate after 7 days of treatment ; | — |
Secondary
| Measure | Time frame |
|---|---|
| recurrence rate;remission time of all symptoms and individual symptoms;SF - 6D Scale;The remission rates of all clinical symptoms and individual symptoms ;TCM syndrome score;Usage rate and days of emergency intervention measure;The disappearance time of all symptoms and individual symptoms;The comprehensive efficacy (both clinical and microbiological response rates are successful);Microbiological response rates ;Clinical response rate after 3, 14, 28 days of treatment;Disappearance rate of all clinical symptoms and individual symptoms;the area under the curve (AUC) of the total score and individual scores of clinical symptom scores;the total and individual scores of clinical symptom scores ; | — |
Countries
China
Contacts
Public ContactJiandong Gao
Shuguang hospital affiliated to Shanghai University of TCM
Outcome results
None listed