Uncomplicated Urinary Tract Infection (UTI)
Conditions
Interventions
Test Group:Luohuazizhu Granules (1 sachet per dose three times daily) + Bazheng Granules Matching Placebo (1 sachet per dose three times daily)
Control Group:Luohuazizhu Granules Matching Placebo (1 sachet per dose three times daily) + Bazheng Granules (1 sachet per dose three times daily)
Sponsors
Xiyuan Hospital China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Female subjects aged =18 and =75 years. (2) Meets the above Western medicine diagnostic criteria for uncomplicated urinary tract infection (UTI). (3) Meets the above TCM syndrome differentiation criteria for Bladder Dampness-Heat Syndrome. (4) Total symptom severity score =15 points with a subscore for urinary frequency urgency and pain =1 point. (5) Urinalysis shows pyuria (urine sediment microscopy >5 white blood cells per high-power field [WBC/HPF]) and/or a positive nitrite test. (6) Presents with at least two of the following symptoms or signs within 72 hours prior to study entry: Dysuria urinary frequency urinary urgency suprapubic pain. (7)Voluntarily participates in this clinical trial and provides written informed consent.
Exclusion criteria
Exclusion criteria: (1) Presence of systemic infection signs such as body temperature >38°C chills or other related clinical manifestations. (2) Indwelling urinary catheter stent placement or intermittent bladder catheterization. (3) Post-void residual urine volume >100 mL. (4) History of obstructive uropathy due to any cause (e.g. bladder outlet obstruction neurogenic bladder stones tumors). (5) History of vesicoureteral reflux. (6) History of urinary diversion surgery. (7) Physical or chemical damage to the urothelium (including radiation therapy or chemotherapy). (8) History of urological surgery within 3 months prior to study entry. (9) History of diabetes mellitus. (10) Current use of immunosuppressive agents. (11) History of =2 culture-confirmed urinary tract infections (UTIs) within the past 6 months or =3 within the past 12 months prior to study entry. (12) Diagnosis of overactive bladder within 3 months prior to study entry. (13) History of tuberculosis AIDS syphilis hepatitis B hepatitis C or gonorrhea. (14) Use of any antimicrobial agent effective against uncomplicated UTI traditional Chinese herbal decoctions proprietary Chinese medicines with similar efficacy or Chinese herbal injections within 48 hours prior to study entry. (15) Known history of allergy to the investigational product or any of its components; history of allergic diseases; or allergic constitution. (16) Impaired/abnormal hepatic or renal function:* Aged =18 and ULN.* Aged =65 and =75 years: AST and/or ALT =2 × ULN; Scr >1.5 × ULN.(ULN = Upper Limit of Normal) (17) Current evidence or history of drug abuse within the past year. (18) History of alcohol dependence. (19) Pregnant or lactating women; or women of childbearing potential who plan to become pregnant from the screening period until 1 month after discontinuation of study medication or who refuse to use effective contraception (i.e. intrauterine device oral contraceptives or barrier methods) during the trial. (20) Presence of any concurrent condition that in the investigator's judgment may interfere with study evaluations such as severe primary diseases of the cardiac cerebral hepatic renal or hematopoietic systems or malignancy. (21) Participation in any other clinical trial within 1 month prior to study entry. (22) Poor compliance as judged by the investigator; unwillingness or inability to adhere to the study medication regimen and follow-up visits. (23) Other factors deemed by the investigator to make the subject unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to complete resolution of urinary tract irritation symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response success rate at Visit 2;Time to resolution of individual symptoms: urinary frequency urgency and dysuria;Time to complete resolution of urinary tract irritation symptoms;Proportion of Subjects Using Rescue Medication During the Study;Change from baseline in disease severity total score at Visit 2;Time to resolution of individual symptoms: urinary frequency urgency and dysuria;TCM Syndrome Efficacy at Visit 2;Comprehensive (Combined Clinical and Microbiological) Response Success Rate at Visit 2;Microbiological Success Rate at Visit 2 (in subjects with bacteriuria confirmed by urine culture at enrollment);Change from baseline in individual TCM syndrome symptom score at Visit 2; | — |
Countries
China
Contacts
Public ContactGao zhan
Xiyuan Hospital China Academy of Chinese Medical Sciences
Outcome results
None listed