recurrent Urinary Tract Infection
Conditions
Interventions
Control group:Control group: cefalexin granule 125mg QD PO
Experimental group 2:Cephalexin granule 125mg QD PO+ Qishao Qinglin prescription QD PO
Experomental group 1:Cephalexin granule simulator QDPO + Qishao Qinglin prescription QDPO
Sponsors
Xiyuan Hospital China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for rUTI as defined in CUA Guidelines for the Diagnosis and Treatment of Urinary System Infections 2022 edition; (2) It meets the diagnostic criteria of Qi-Yin deficiency syndrome in accordance with the Clinical Practice Guidelines for the Treatment of Common Infectious Diseases with Traditional Chinese Medicine Alone/Combined Antibiotics · Simple Lower Urinary Tract Infection; (3) Female patients aged =18 years and =80 years; (4) rUTI remission stage at the time of enrollment: no obvious symptoms of urinary tract irritation white blood cell count in midstream urine analysis was in the normal range leukocyte esterase and nitrite were negative and urine bacterial culture was negative; (5) Clear consciousness able to answer questions independently able to complete relevant questionnaires according to the requirements of the experiment; (6) I volunteer to be tested and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients allergic to the investigational drug; (2) Patients who had taken the experimental drug cefalexin before enrollment; (3) any complex signs of urinary tract infection or pyelonephritis (manifested by low back pain fever =37.3°C systemic symptoms); (4) Drugs affecting immune function (including immunosuppressive drugs such as glucocorticoids and neurocalcin inhibitors etc.) should be used within 7 days before randomization or expected after enrollment; Immune-enhancing drugs: such as BCG vaccine levamisole thymosin etc.); (5) Patients with urinary tract anatomic function abnormalities (such as urinary tract obstruction stones or congenital urinary tract malformations) and/or residual urine > 50ml; (6) Patients with urinary system underlying diseases such as obstruction calculus urinary stenosis vesicoureteral reflux or other functional abnormalities urine diversion indwelling catheter or stent tube or intermittent catheterization; (7) Gynecological examination of gynecological anatomical malformations and gynecological reproductive tract infections and other diseases; (8) Combined or existing systemic lupus erythematosus AIDS diabetes poor blood sugar control (HBA1c > 8.5% fasting blood sugar > 10mmol/L) and other diseases that can lead to systemic immune dysfunction; (9) Patients with malignant tumors and mental patients; (10) Patients with a need to prepare for pregnancy known/suspected pregnancy breastfeeding or planning pregnancy within 3 months after withdrawal of medication; (11) Those who have received any other investigational drug treatment or participated in another interventional clinical trial within 4 weeks prior to screening; (12) Failure to comply with the test protocol or other conditions deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ICIQ-FLUTS points; | — |
Secondary
| Measure | Time frame |
|---|---|
| Urine analysis: including urinary leukocytes leukocyte esterase nitrite.;Recurrence rate recurrence time and resistance rate of pathogenic bacteria after recurrence;Urine antimicrobial peptide LL-37 SlgA levels;Determination of peripheral blood FOXP3+ regulatory T cells;TCM syndrome integral of rUTI Qi and Yin deficiency syndrome;Urine bacterial culture; | — |
Countries
China
Contacts
Public ContactJiaSenDing
Xiyuan Hospital China Academy of Chinese Medical Sciences
Outcome results
None listed